The Clinical Study Director (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.
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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, written subject information, trial disclosure form, case report form, study plans (eg: study risk management plan, central monitoring plan), study reports, material for training and meetings (such as investigator meetings). Contribute to publications and communications of results. Potentially write ES in some specific cases (eg: Medical Affairs studies).
Collaborate and communicate appropriately with all stakeholders for optimal study execution, including but not limited to: 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, CRO’s and regulatory affairs
Challenge appropriately the study extended synopsis based on feasibility pre-assessment, protocol complexity index and associated cost.
Responsible and accountable for overall supervision/execution of medical validation/review of study data, including writing or supervision of study related documents (eg: medical review plan, guidelines, etc.)
Key role 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.
The CSD participates in transversal taskforces, working groups, best practice initiatives and project or therapeutic area meetings, as required
The CSD may endorse the role of DPE, where he/she is the key medical reference for the compound in Medical Operations, ensures uniform, aligned operational approach (eg. harmonizing study documents, ES, 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 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.
Qualifications
Licensed Medical Doctor: GP or specialist,
Minimum 3 year in pharmaceutical industry or CRO
Minimum of 3 years of academic experience as an investigator
Strong Scientific and medical expertise
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
Strong negotiation skills
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
Preferred experience
Previous experience in clinical development
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