Open Positions

Description

• Primary Responsibilities:
  The Medical Writer will research, create, edit, and coordinate the production of clinical and regulatory
  submission documents, including clinical study reports, protocols, and safety update reports, etc.
  The Medical Writer may provide writing support for more complex clinical documentation, with
  appropriate departmental supervision. The Medical Writer may serve as primary technical contact with
  client under appropriate departmental supervision.
• Key responsibilities and skills may include, but are not limited to:
  • Serve as the primary client contact under departmentalsupervision.
  • Serve as the Medical Writing representative on assigned project teams, providing support to
  Project for developing efficient work plans and timelines for medical writing deliverables, and
  medical writing input into other departmental deliverables.
  • Providing support to Business Development Department for project bidding, document review and
  forecasting timeline.
  • Write clinical documents associated with submissions to regulatory authorities.
  • Serve as QCer to review peer`s clinical documents.
  • Provide medical editing review of draft and final documents prepared by other writers before
  internal or external distribution. This includes both copy editing and contentreview.
  • Ensure document content and style adheres to appropriate regulatory guidelines and complies
  with departmental and corporate or client SOPs and style guidelines.
  • Coordinate production and distribution of draft and final documents to project team and client.
  Ensure that all work is complete and of high quality prior to team distribution or shipment toclient.
  • Perform literature searches/reviews as necessary to obtain background information and training
  for development of documents.
  • Attend internal technical team and client team meetings as required.
  • Keep abreast of professional information and technology through workshops and conferences and
  ensure the appropriate transfer of that information to the department.
  • Participate in departmental or interdepartmental process improvement and training initiatives.
  • Other assignment duties as assigned by department management.

Requirements

• Qualification: Bachelor’s degree or above in Life Sciences/Health Related Sciences or equivalent.

Years of Experience

• Should have experience of 4-8 years of medical writing of regulatory documents such as CSR, protocol or similar in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications.

Skills

• • Experience in the pharmaceutical industry or medical writing.
• • Good clinical/scientific writing skills.
  • Excellent interpersonal, verbal and written communication skills.
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with      attention to detail.
  • Good word processing skills/familiarity with Word for Windows.
  • Experience with eCTD preferred.

Description

• Provide operational support within the team to execute designated tasks associated with submission.
• coordination activities for assigned products and/or at required dossier execution process workflow as
• Accountable for delivering designated submissions with quality and timely as per applicable policy, SOP/Work.
• Instructions, guidelines, or service level agreement.
• Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
• Escalate, inform, and/or resolve any issues that may impact timeline, quality, or compliance of submissions.
• Commit to completing required on-the-job training courses to ensure training compliance is preserved.
• Promotes the use of Document Management and Archival systems and standard document authoring and publishing processes, partnering with supplier groups as necessary to produce timely delivery of
• submission/archive ready components.
• Commit to completing required on-the-job training courses and Curriculum to ensure compliance is preserved.
• Execute regional specific tasks to support on time project delivery.
• Able to operate at pace with agile decision-making skills. Uses evidence and applies judgment to balance pace, rigour, and risk.
• Command necessary knowledge and skills of regional submissions and ensure regulatory or business requirements are fulfilled.

Requirements

• Qualification: Bachelor’s / Master’s degree in pharma or lifesciences.

Skills

• Experience in managing in a matrix environment
• Proven experience in decision making and tight deadlines
• Customer service experience
• Technically adept using IT systems and software
• General understanding of healthcare regulatory environment
• Fast learner with proven ability to adapt to changing demands

• Interested candidates can share their updated CVs to milanashree.r@clinchoice.com

Description

• Performing QA functions pertaining to (but not limited to) Change management, CAPA, Deviation, Internal Audits, External Audits, Risk management, Innovation and Continual improvement.
• Understanding GXP requirements such as (but not limited to) GCP, GVP, GMP, GDocP etc. and implementing/ monitoring them for QA function, as applicable.
• Facilitating the process of initiation of investigations and CAPAs, monitor progress and perform reviews/approvals.
• Ensuring that CAPA procedures and requirements are followed and met. Uphold standards for quality and compliance in pharmacovigilance.
• Escalating and involve stakeholders for resolution as needed, issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records.
• Reviewing evidence and approve closure of CAPA plans and effectiveness monitoring plans.
• Facilitating regular CAPA status and metric reports to ensure senior management awareness.
• Participating in governance/oversight activities including trend assessment or other quality review.

Requirements

• Qualification: Bachelor’s Degree or equivalent University Degree in scientific

Years of Experience

• Should have 5 to 10 years of relevant experience.

Skills

• Quality Assurance
• Nonconformance management (CAPA, Deviations, Issues)
• GCP/ GVP
• Stakeholder management
• Conflict Resolution

• Interested candidates can share their updated CVs to saba.naaz@clinchoice.com

Description

• Participate in requirements analysis.
• Collaborate with internal teams to produce software design and architecture.
• Write backend code using .NET programming languages .
• Create Front-end (UI) using VUE.js.
• Test and deploy applications and manage systems.
• Revise, update, refactor and debug code.
• Improve/Enhance the existing software.
• Prepare documentation throughout the software development life cycle (SDLC).
• Provide technical support in application development.
• Interacting with testing team and resolve the bugs/issues reported.

Requirements

• Qualification: Graduate or post graduate in computer science or equivalent degree.

Years of Experience

• Should have 5-6 years of experience in Microsoft .Net Technologies, with strong programming skill in (Vue.Js, Typescript, .NET Core (.NET 6 /.NET 7 will be added advantage) , CSS ,C#,ADO.NET, HTML5, JavaScript, Bootstrap ,Entity Framework Core, REST API,SQL Server, Unit Testing Automation(NUnit or XUnit) ).

Skills

• Deep understanding of Object-Oriented patterns and principles.
• Should have knowledge of Entity Framework Core.
• Should have a good knowledge on MVC architecture.
• Candidate must be able to work independently.
• Should have knowledge on design pattern.
• Should have knowledge on ORM (Object Relational Mapping).
• Should have good knowledge on web API development.

• Note: – Knowledge on Dev Ops, GIT, SQL Server, Docker and Kubernetes will be added an advantage.

• Interested candidates can share their updated CVs to saba.naaz@clinchoice.com

Description

• QA responsibilities include:
  • Performing QA functions pertaining to (but not limited to) Change management, CAPA, Deviation,
  Internal Audits, External Audits, Risk management, Innovation and Continual improvement.
  • Understanding GXP requirements such as (but not limited to) GCP, GVP, GMP, GDocP etc. and
  implementing/ monitoring them for QA function, as applicable.
  • Facilitating the process of initiation of investigations and CAPAs, monitor progress and perform
  reviews/approvals.
  • Ensuring that CAPA procedures and requirements are followed and met. Uphold standards for
  quality and compliance in pharmacovigilance.
  • Escalating and involve stakeholders for resolution as needed, issues impacting the progress toward
  completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records.
  • Reviewing evidence and approve closure of CAPA plans and effectiveness monitoring plans.
  • Facilitating regular CAPA status and metric reports to ensure senior management awareness.
  • Participating in governance/oversight activities including trend assessment or other quality review.
• CRA responsibilities include:
  • The Clinical Research Associate III (CRA III) monitors clinical studies and assures high quality of the
  clinical data.
  • Keeps him/herself professionally abreast of all scientific, regulatory and operational aspects
  relevant to the clinical projects he/she will be assigned
  • Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by
  obtaining the pre-study documentation to ensure good start-up of the investigation sites
  • May acts as Feasibility Associate (FEA) after appropriate and documented training
  • Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP
  compliance
  • Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy,
  legibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol,
  SOP’s and ICH-GCP requirements in order to ensure data integrity and subject safety
  • Attends and may present at Investigator Meetings (IM) and study specific training meetings.
  • May translate, coordinate translations or review completed translations of critical documents.
  • Conducts source data verification and in house review of clinical data and ensuring timely
  resolution of data queries to guarantee reliable clinical data
  • Manages the investigational products (storage, inventory, dispensing records, packaging and
  labelling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc) to
  ensure timely and correct supply to the site
  • Cooperates with the site staff for ensuring a proper reporting from the site of the safety issues
  (adverse events and adverse reaction such as AEs/SAEs, SUSARs, etc.) and their follow up,
  guaranteeing timely and appropriate handling of safety issues
  • Conducts and reports study termination and related activities (e.g. archiving) guaranteeing
  smooth completion of the project
  • Is the main contact person for the site in order to ensure close follow up
  • Provides general support to the Clinical Research Division (CRDIV) on quality control of clinical
  data
  • Promptly addresses the Projects Coordinators (PCs)/ Project Managers (PMs)/ Senior Project
  Managers (SPMs) about any issues that can jeopardize the conduct of the clinical projects
  assigned
  • Reports to the Head of Clinical Monitoring Unit (CMU-H) or delegate on all activities performed
  during the study and sends all relevant documents according to the timelines and the
  requirements agreed for each single clinical trial
  • Develops training material and gives trainings to CRDIV in collaboration with the Training &
  Qualification Management Unit (TQMU)
  • May assist in contract negotiation with sites on study budget after appropriate and documented
  training
  • Assists the preparation of the study including CRF design/development, writes CRF instructions,
  organizes the study files and documents to ensure good start-up of the investigation sites
  • May support the submission process in the project (or region), including submission
  requirements, timelines, informed consent development, etc. after appropriate and
  documented training. Accordingly he/she can be required to provide updates on the applicable
  regulation for the application process in the country of work, whenever relevant
  • Guides and supervises Clinical Research Associates I (CRAs I)/ Clinical Research Associates II
  (CRAs II) in order to coach and train them on the job
  • Perform co-visits with Clinical Research Associates I (CRAs I)/ Clinical Research Associates II
  (CRAs II)

Requirements

• Qualification:  Should have Bachelor’s Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred. In some cases an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Years of Experience

• Should have Eight (8) years (at least) of experience as a CRA

Skills

• • Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable
  regulatory requirements
  • Sound knowledge of medical terminology.
  • Ability to manage more than 1 study simultaneously.
  • Fluent in English and local language(s)
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness and ability to travel up to 50-80%, this may increase or decrease depending on the
  project needs.

• Interested candidates can share their updated CVs to saba.naaz@clinchoice.com

Description

• Support regulatory activities and license maintenance of assigned product portfolios.
• Support IDMP and XeVMPD data readiness.
• Execute CMC package building and approval in client system.
• Support labeling and annual reports submission.
• Coordinate with the local regulatory affiliates to collect the necessary information and raise request for required certificates.
• Coordinate with client vendor for legalization by ensuring all relevant data is provided including payment.
• Respond to questions, if any and ensure the certificate is issued and legalized within the agreed timeline.
• Track all submission requests simultaneously to ensure submission timeline is adhered.
• Any delay in the process to be escalated to client stakeholders.
• Drug listing activities for the approved products and other product licensing support activities to maintain compliance.
• Actively participate in cross-functional teams as appropriate.
• Development and maintenance of documented procedures and guidelines as necessary.
• Compliance with client’s SOPs/Work Instructions and other standards, as applicable.
• Ensure quality is maintained in all data entry and other regulatory operations activities.

Requirements

• Qualification: Bachelor’s Degree desirable.

Years of Experience

• Should have 0-2 years of relevant experience.

Skills

• Demonstrated ability to work within a demanding environment with a strong focus on quality and timelines.
• Fundamental knowledge of CMC and other regulatory submissions.
• Proven technical aptitude and ability to quickly learn and apply new software, regulations, and quality standards.
• Can demonstrate proactiveness and capabilities to manage tasks independently. Has good collaborative skills.
• Advanced Microsoft Office Suite skills.
• Should have excellent verbal & written English communication skills.
• Acts decisively and seizes accountability.

• Interested candidates can share their updated CVs to milanashree.r@clinchoice.com

Description

• Primary Responsibilities:
  The Medical Writer will research, create, edit, and coordinate the production of clinical and regulatory submission documents, including clinical study reports, protocols, CTD sections, IB, and safety update reports, etc.
  The Medical Writer may provide writing support for more complex clinical documentation, with appropriate departmental supervision. The Medical Writer may serve as primary technical contact with client under appropriate departmental supervision.
  Key responsibilities and skills may include, but are not limited to:
  • Serve as the primary client contact under departmental supervision.
  • Serve as the Medical Writing representative on assigned project teams, providing support to Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables.
  • Providing support to Business Development Department for project bidding, document review and forecasting timeline.
  • Write /Review clinical documents associated with submissions to regulatory authorities.
  • Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
  • Ensure document content and style adheres to appropriate regulatory guidelines and complies with departmental and corporate or client SOPs and style guidelines.
  • Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
  • Coordinate production and distribution of draft and final documents to project team and client.
  Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
  • Attend internal technical team and client team meetings as required.
  • Keep abreast of professional information and technology through workshops and conferences and ensure the appropriate transfer of that information to the department.
  • Participate in departmental or interdepartmental process improvement and training initiatives.
  • Other assignment duties as assigned by department management.

Requirements

• Qualification: Bachelor’s degree or above in Life Sciences/Health Related Sciences or equivalent.

Years of Experience

• Should have 10-13 years of experience in medical writing of regulatory documents such as CSR, protocol, CTD sections or similar in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications.

Skills

• • Experience in the pharmaceutical industry or medical writing. Specific experience in Oncology and Neurology Therapeutic areas.
• • Good clinical/scientific writing skills.
  • Excellent interpersonal, verbal, and written communication skills.
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
  • Good word processing skills/familiarity with Word for Windows.
  • Experience with eCTD preferred.

• Interested candidates can share their updated CVs to megha.chinnappa@clinchoice.com / preetham.d@clinchoice.com

Description

• Provide statistical oversight to studies and assure adequate quality and consistency with project requirements. Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

Primary Responsibilities:

• Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
  Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
  Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
  Responsible for validity of analysis and explore alternative analysis strategies as needed.
  Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
  Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
  Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
  Effectively mentor peers with regard to statistical methodology and provide appropriate training to less experienced statisticians.

Requirements

• Qualification – MSc or PhD in Statistics, Biostatistics or related field.

Years of Experience

• Should have 5 to 10 years of experience as Biostatistician.

Skills

• Strong oral and written communication skills, with ability to communicate effectively internally and with clients.
  Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
  Pharmaceutical or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.

• Interested candidates can share their updated CVs to ramyashree.hv@clinchoice.com

Description

Position: Principal Statistical Programmer(Clinical Trials)

Employment type: FTE or contract

(REMOTE in EU/UK)

About ClinChoice

ClinChoice is a Global CRO dedicated to offering high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major delivery centers across the US, Canada, China, Europe, India, Japan, and the Philippines. It has over 3,000 employees globally, a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America, and Europe.

Summary

The Principal Programmer is accountable for the quality, timely, and efficient delivery of the project

programming work and good information management. This position requires profound programming experience and excellent industry knowledge to independently lead the implementation of programming activities as well as lead other programmers. It is a leadership role that can have a project or technical focus It will provide subject matter expertise within the Programming discipline. As an expert within their own field acts as a specialist within cross-functional teams to deliver continuous improvement

NOTE-If now is not the right time we would still be very interested in discussing our FSP contract brand for future opportunities. We are a Biometrics CRO that contracts directly with professionals. Feel free to contact us at clinchoice-career@clinchoice.com.

Responsibilities

• Leads and directs the full scope of project delivery and/or leads a technical project within the

TA/Drug Project/study/function

• Leads Implementation of statistical programming aspects of the protocol or clinical development

program

• Responsible for the high quality of all project deliverables, holding partners, and providers

accountable for the quality of their deliverable and/or technical subject matter expert for aspect(s)

of the TA, Project, or function

• Leads or contribute to cross-functional administrative or process improvement initiative(s)

• Drives the development of best practices to improve quality, efficiency, and/or effectiveness

within the function

• Drives standards development and implementation

• Manages and escalate risk in complicated or novel situations within their study and/or projects

• Provides Programming expertise to the team

• Provides tactical input and/or drives ideas and improvements

• Contributes to the function by supporting recruiting and/or providing training and mentorship

• Identifies opportunities to improve methodology and provides practical solutions for problems

• Influences stakeholders by providing subject matter expertise on programming-related items

• Ensures compliance with standards and automation usage

• Employs all project management practices in managing drug or technical projects

• Provides input to capacity management for all projects in scope

• Maintains expertise in the latest industry and regulatory requirements to stay current

Qualifications and Experience

• Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life

Science or equivalent with 8+ years of related experience in programming. 

• Proven programming expertise

• Thorough knowledge of the clinical development process

• Thorough knowledge of industry standards and ability to implement them

• Ability to apply programming expertise to problem-solving and troubleshooting for teams

• Current knowledge of technical and regulatory requirements relevant to the role

• Ability to proactively manage concurrent activities within a project

• Proficient ability to influence relevant stakeholders on programming-related items

• Ability to manage risk in complicated or novel situations

· • Project Mindset

ClinChoice is an Equal Opportunity Employer / Committed to Diversity

Description

Title: Senior Biostatistician-Late Phase
Employment type: FTE OR Contract

100% Remote anywhere in EU/UK

About ClinChoice

ClinChoice is a global CRO dedicated to offering high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major delivery centers across US, Canada, China, Europe, India, Japan, and the Philippines. It has over 3,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America, and Europe.

NOTE-If now is not the right time we would still be very interested in discussing our FSP contract brand for future opportunities. We are a Biometrics CRO that contracts directly with professionals. Feel free to contact us at clinchoice-career@clinchoice.com

Summary
Assignments for Senior Biostatistician Consultant are to provide Biostatistical support and work on key client deliverables involving designing and analyzing clinical trials.

Key responsibilities include, but are not limited to:

• 3+ years’ experience preferred leading late-phase studies.
• Modeling experiences such as Mixed Models, Cox Models, Kaplan, Mier Estimates, and Poison Modeling would be a plus.
• Protocol development including study design, sample size estimation, randomization, and statistical analysis plan for assigned studies.
• Statistical oversight of studies and assure adequate quality and consistency with project requirements.
• Responsible for the accuracy and completeness of database quality checks and assuring that data for statistical analyses are complete, accurate, and consistent.
• Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
• Responsible for the validity of the analysis and alternative analysis strategies when unforeseen circumstances arise.
• Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
• Responsible for the accuracy and consistency of statistical tables, figures, and data listings, the accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
• Responsible for the statistical methods section of the reports. Identifies and corrects flaws in the interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
• Effectively coordinate assignments and review deliverables so that projects are delivered on time with high quality.
• Other duties and responsibilities as required and depending on specifics of client projects

Requirements:

• MS or Ph.D. in Statistics, Biostatistics, or a related field. Ph.D. with 4+ years of related experience, or MS with 6+ years of experience.
• A high degree of technical competence and communication skill, both oral and written.
• Competent in experimental design, descriptive and inferential statistics.
• Pharmaceutical, CRO, or related industry experience with clinical trials.

Clinchoice is an Equal opportunity Employer/committed to diversity