Published
February 4, 2020
Location
Bridgewater Township, New Jersey
Job Type
Work Setting
Remote / Home-based

Description

The role of the Clinical Study Director (CSD) is to provide medical expertise for:

  • The clinical studies (except Clinical & Exploratory Pharmacology studies) and/or registries to be carried out by Clinical Sciences & Operations (eg: protocol, Key Results Memo, Clinical Study Report).
  • Other clinical development activities (e.g. protocol optimization, medical review and validation of clinical data, study risk assessment).
  • Contribute to the clinical part of Common Technical Document for FDA & EMA submission, answers to questions from health authorities for submission dossier).
  • The CSD will provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators.
  • The CSD will be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data.
  • He/she will have to interact with Strategic Units/Divisions/Franchise, Regulatory, Pharmacovigilance (CME, GSO), Project Leaders from CSO, feasibility managers, CTOMs, biostatisticians, Clinical Documentation (Medical Writers), Monitoring team, Coding team, and for the studies from the Medical Affairs (global or regional) with Medico-marketing representatives from the appropriate departments.
  • The CSD may act as a Dedicated Project Expert (DPE) in Medical Operations, and may mentor other CSDs and CS on a same project TA.

MAJOR DUTIES AND RESPONSIBILITIES:

  • Provide expertise and act as a reference for all medical operational activities related to the projects/studies he/she is assigned to.
  • Write/contribute/review/QC/validate study related documents: clinical protocols, CSICF, TDF, study plans (eg: study risk management plan, central monitoring plan), study reports, material for training and meetings (such as investigators Meetings). Contribute to/review abbreviated protocol, publications, and communications of results.
  • Collaborate and communicate appropriately with all stakeholders for optimal study
    • feasibility managers for feasibility preparation and validation of feasibility results
    • Clinical Scientists, Medical review team and Coding
    • Pharmacovigilance (GSO, CME) as regard to safety management and case processing
    • CTOMs, Biostatisticians
    • CSU medical advisors for the best knowledge of the study, compound, protocol
    • Units/Divisions and medical affairs
    • CROs
    • Regulatory affairs
  • Execution, including but not limited to:
  • Review abbreviated protocol based on feasibility, protocol complexity index,  associated cost, and even strategy, if appropriate.
  • Responsible and accountable for overall supervision/execution of medical validation/review of study data, including writing or supervision of study related documents (eg: centralized monitoring plan, guidelines, etc…).
  • Is key player to organize/contribute and/or participate in Investigators’ Meetings, Steering Committees, Data Monitoring Committees Meetings, adjudication committees and prepare related material (eg charter, presentations).
  • Provide medical answers to questions from Health Authorities, IRB/Ethics Committees, Investigators, experts, clinical study team.
  • Secure CSD trial master file documents readiness and availability, and mandatory trainings linked to the function.
  • Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc).
  • Key role with Medical Writer to develop, review and finalize study protocols and reports.
  • Maintain medical expertise in the therapeutic domain.
  • Participates in transversal taskforces, working groups, best practice initiatives and project or therapeutic area meetings, as required.
  • The CSD may include the role of DPE (depending on experience), where he/she is the key medical reference for the compound in Medical Operations, ensures uniform, aligned operational approach (eg harmonizing study documents, abbreviated protocols, protocols, etc), as relevant, within a project, ensures leadership, builds consensus, coordinates action plans with other CSDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to CSO and Division/Unit partners, as relevant and shares relevant information within Medical Operations (eg CSDs, Clinical Scientists).
  • The DPE-CSD may have a mentoring and/or supervising role of more junior CSDs and Clinical Scientists supporting the studies within the same project or in the same therapeutic area/indication that he/she is in charge of.
  • Good relationship with partners/units for developing trust and effectiveness.
    Integration and collaboration with CTT members and CSUs (especially Medical Advisors).
  • Demonstrated leadership.
  • Establish and maintain a good relationship with Key Opinion Leaders and Investigators.
  • Medical representatives in Units for the Units studies, in Divisions for the Divisions studies, medico-marketing representatives for the Medical Affairs studies, other customers. Feasibility managers, coding specialists; CTOMs, biostatisticians and other CTT members; CSUs Medical Advisors; GPE: Case Medical Evaluators, Global Safety Officers; CSO Project Leaders.
  • Decision making authority on Feasibility, medical issues, recruitment strategy, retention plan, study risk management.
  • Negotiations of medical matters with Investigators, Experts, internal units/customers and CROs.

BASIC QUALIFICATIONS:

  • M.D. degree (or equivalent) required
  • Minimum of 3 years in pharmaceutical industry or CRO with previous experience in clinical development OR minimum of 3 years of academic experience as investigator
  • English fluent (spoken and written)

PREFERRED QUALIFICATIONS:

  • Active U.S. Medical license, OR ECFMG certification preferred.
  • Ideal candidate has a specialization in Dermatology, Pulmonology, or Rheumatology.
  • Strong Scientific and medical expertise
  • Experience in project management is preferred.
  • Experience in clinical development and methodology of clinical studies
  • Demonstrated leadership
  • Quality focused and well organized
  • Strong communication skills (verbal and written)
  • Ability to handle multiple tasks and to prioritize
  • Ability to synthesize the information, good presentation skills
  • Ability to make decisions
  • Capability to challenge decision and status quo
  • Ability to negotiate
  • Ability to work autonomously and to efficiently & effectively provide status reports
  • Ability to develop an holistic approach as regard to study conduct
  • Ability to anticipate and timely escalate issues and to define appropriate action plans
  • Team and results oriented
  • Teaching skills, ability to assist and train others
  • Ability to work within a matrix model
Apply
https://www.linkedin.com/in/your_name/
Drop files here browse files ...
Resume, cover letter, or other documents as required per the job description

Related Jobs

Remote Senior Medical Writer   Remote, United States of America new
February 12, 2020
Chief Medical Officer   Philadelphia, Pennsylvania new
February 12, 2020
February 12, 2020
Physician Advisor   Remote, United States of America new
February 12, 2020
Vice President Quality Metrics and Performance   Remote, United States of America new
February 11, 2020
Are you sure you want to delete this file?
/