Our client, a leading pharmaceutical company is looking for a Manager, Clinical Operations to join their team.
- Manage the process of screening, qualifying, and selecting, and contracting with investigators, sites and vendors required for conduct of clinical trial.
- Ensure studies are on track for site initiation, patient recruitment, and enrollment, and take corrective actions where necessary to address issues.
- Develop SOPs and work instructions to assure internal files and clinical study files conform to Good Clinical Practice regulations and standards.
- Maintain surveillance of published literature/clinical results and competitive products across all pertinent indications for strategic purposes and use in regulatory submissions.
- Develops budgets for all clinical projects and adheres to company financial goals.
- Undergraduate university degree in life sciences (BSc.)
- Master’s degree in life sciences or higher, preferred.
- Minimum of 7 years of relevant clinical research experience in an industry
- Experience in drug development in oncology, cardiology and/or immunology.
- Experience in radiopharmaceutical, an asset.
- Familiar with global regulatory and compliance requirements for clinical research including but not limited to US CFR, EU CTD, and ICH GCP.
- Excellent adaptability and flexibility.
- Excellent capacity for analysis, good judgment, and critical skills
- Capacity to prioritize and execute several projects at the same time and with a minimal supervision.
- Strong leadership and team spirit
- Ability to work in a fast-paced environment.
- Effective communication skills, both verbal and written.
Please submit your resume directly to Céline Chabée at email@example.com, indicating “Manager, Clinical Operations” in the title of the email.
Only selected candidates will be contacted.