Clinical Study Director (CSD) will report to the Group Leader of Medical Operations Group 2 in the Medical Operations Department within the Clinical Sciences & Operations platform/ CSO.
The Medical Operations Group 2 team is responsible for phase 2/3/4 clinical research studies conducted in Immuno-inflammation and Infectious Diseases.
The proposed position will be focused on phase 2B/3/4 clinical studies in the therapeutic areas of asthma, upper respiratory disease and rheumatologic (e.g., RA) conditions.
Key Accountabilities Of The Clinical Study Director
Duties
The CSD is the study leader/study champion. The main responsibility of the CSD is to provide medical oversight, expert medical input and leadership to the clinical trial team to ensure optimal study execution. Working within this capacity, the CSD will carry out the following duties:
· Review/comment (or in certain situations author) Extended Synopses for clinical study protocols
· Prepare protocol presentation, and develop questionnaires to support Feasibility Manager for Feasibility Study and contribute to the validation of the Feasibility Report
· Lead author for clinical study protocols and written subject information documents
· Lead author for Steering Committee, Adjudication Committee, Safety Committee charter(s) as required per project
· Review/approve clinical study-related documents (for example, vender specifications for centralized services, such as, centralized ECG, clinical laboratory, IVRS/IWRS, eDiary, spirometry, bone imaging, CT, MRI, and endoscopy services)
· Review and approve eCRFs and user instructions
· Review and approve Patient User Instructions
· Provide medical expertise and study guidance to clinical trials operations managers
· Provide medical oversight of clinical trials: Work with Pharmacovigilance/Global Safety officer in case of SAE/SUSAR, perform medical review, participate in Safety Management Meetings, identify potential safety signals during Data Review and Surveillance meetings, and in advance of DMC meetings, review/identify potential safety signals in internal DMC package
· Key role to present protocol and address study-related questions at Global (or in certain cases Regional/Local) Investigator Meetings, Study Coordinator/CRA Training
· Key role in the preparation, organization and participation at Investigator Meetings, Steering Committee meetings, Safety/Adjudication Committee Meetings, Advisory Committee Meetings
· Key collaborator with Medical Writing to develop, review and finalize clinical study reports
· Establish relationships with key external clinical advisors and organize Advisory Committee Meetings as required
· Maintain medical expertise in Immuno-inflammation
Job
Clinical Development
Primary Location
United States-Massachusetts-Cambridge (U.S.)
Basic Qualifications
· MD
· Board certified
· 2-5 years working in clinical research & development setting
Preferred Qualifications
· Subspecialty/fellowship (or related experience) training in the field of Pulmonary / Immunology, Allergy, and/or Rheumatology desired
· Knowledge in ICH, GCP and local regulations
· Fluent in English (writing and speaking)
· Strong Interpersonal skills and negotiation ability
· Ability to influence others in fully matrixed, team setting
· Foster team spirit and support the development of strong clinical trial teams
· Ability to develop strong relationships (within office setting and working remote) with: Country-specific Medical Advisors/ Local Teams (CSUs), Clinical Research Directors in corporate Strategic Units, Global Safety Officers/Pharmacovigilance Dept., Clinical Coding Specialists, External Partners, etc.
· Demonstrated ability to author scientific documents, such as study protocols, DMC charters, clinical abstracts
· Ability to travel
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