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.
- Life Sciences Degree, PhD preferable but not essential;
- At least 5 years’ experience within the Medical Device or Pharma industry.