Clinical Affairs Manager Job Description

Clinical Affairs Manager Job Description Template

Our company is looking for a Clinical Affairs Manager to join our team.

Responsible for the development and publication of all relevant clinical study reports and peer reviewed papers;
Responsible for setting and agreeing clinical budgets across our business units in line with corporate objectives;
Manage and execute all post-market clinical research studies and surveys;
Conduct literature searches and obtain electronic versions of articles in support of ongoing bibliography and reviews;
Ensure compliance with legal and regulatory requirements (e.g., GCP, ISO standards, MDD and MDR guidelines);
Ensure all clinical activities conducted are in a timely manner and within site budgets;
Ensure all completed CER’s approved are (externally) and registered via the recognised systems and processes across both our brands (internally);
Develop reports for submission to regulatory agencies, as needed;
To undertake any other reasonable duties;
Monitor and ensure audit readiness of clinical study data and documents at sites to ensure regulatory and protocol compliance;
Develop and maintain (pre and post- market) clinical strategies to meet current and future business needs (e.g. new products. regulatory and customer);
Responsible for developing and implementing all Clinical Evaluation Reports, as per agreed plans, in compliance with current and changing regulations;
Provide clinical input into business processes (e.g. marketing, new products);
Support data analyses and publication/presentation generation.