Study Responsible Physician (FSP)

Parexel International Corporation

United Kingdom - Any Region - Home Based

Responsibilities:

General Operational:

Execute study related activities in accordance with Participating Affiliate Study Responsible Physician (SRP) Standard Operating Procedures (SOP), Company Policy and the Protocol.

Medical Oversight:

Oversee the medical and scientific integrity of study design and execution Provide medical oversight to ensure subject safety is first priority Specific to each assigned study/studies, relating to above mentioned SOPs: Provide medical and scientific input to protocol development, amendments and other related study documents, such as the informed consent form. Provide medical and scientific input for the identification and feasibility analysis of new countries and investigational sites Provide medical and scientific input into the generation of the ethics/regulatory submission documents and provide responses to ethics committee/regulatory authority questions Provide medical input into eCRF/database modifications Develop, maintain and execute the Medical Review Plan Prepare Study Specific Safety Summary, per request from global pharmacovigilance Provide medical and scientific input to the development of interim and final Statistical Analysis Plans, top line results and final analysis Perform medical review and approval of clinical study reports, both interim and final, relevant data line listings and safety reports Respond to study specific medical questions Provide medical content and/or conduct review and approval of study-related items, including but not limited to presentation slide decks, training materials, patient information materials Provide medical and scientific input to study-related publications

Additionally, the role-holder may be requested to engage in the following support activities for the assigned study/studies per approval of the Study Team Lead: Attend central study team meetings Attend and provide study team training Participate in ad hoc country visits, local and international investigator meetings Attend scientific congresses, either external or internal scientific meetings, to enhance knowledge, dissemination and/or profile of the study Participate and provide medical and scientific input into publication strategy QualificationsMust be a Physician/MD.

• Fluency in English language required

• Fluency in additional languages is an advantage

• Good knowledge of the disease area in general with a good knowledge of all products within oncology disease area

• In-depth knowledge and hands-on experience of clinical trial design and study data analysis (e.g. statistical analysis) and Clinical Data interpretation

• Excellent knowledge of global regulatory and GCP requirements

• Excellent knowledge of study execution, Global Medical Safety and regulatory affairs

• Excellent knowledge of Global and Local SOPs

• Good knowledge of study publication processes

• Ability to work effectively in a matrix environment

• Capable of working in multi-cultural, virtual teams

#LI-REMOTE


2022-07-30 00:05:20


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