Global Life Science Hub is working with a prominent clinical research organization that is partnered with a well-known pharmaceutical company. They are in search of a Senior Clinical Start-Up Officer to join their dynamic team on a sponsor dedicated basis. This is a fantastic opportunity to contribute to high-profile projects and collaborate with industry leaders in a highly regarded clinical research environment.
We are excited to present this opportunity to our client, a leading clinical research organization. The Senior Clinical Start-Up Officer role is at the heart of their operations, involving the coordination and execution of regulatory submissions in strict compliance with contract terms, ICH GCP guidelines, SOPs, and national/international regulations. The successful candidate will work closely with cross-functional teams to ensure project timelines, key milestones, and the quality of deliverables are met.
- Manage the submission of Interventional Clinical Trials to Authorities, primarily adhering to CTR 536/2014 and Directive 2001/20/EC.
- Coordinate the collection and preparation of documents required for regulatory start-up submissions of clinical studies.
- Compile submission folders for regulatory and statutory submissions as necessary.
- Develop proposals, create contracts, and foster strong customer service relationships for assigned projects.
- Cultivate professional relationships with Ethics Committees, Regulatory agencies, and other relevant institutions to facilitate submissions and approvals.
- Track submissions and update relevant tracking systems.
- Prepare or review invoices against signed contracts and approved budgets.
- Attend project meetings and interact with stakeholders when necessary.
- Participate in team meetings, document meeting minutes, and distribute them to the team.
- Maintain project/study contact lists for project/study teams and sites where applicable.
- Provide valuable input in the creation, update, and maintenance of policies and procedures within your area of expertise and role.
- Contribute to the development of SOPs and other company initiatives as required.
- Bachelor’s Degree in a related field or equivalent, with a preference for a health-related field.
- A minimum of 2 years of relevant work experience in Interventional Clinical Studies.
- Working knowledge of current regulations related to clinical research.
- Strong interpersonal, communication, organizational, and problem-solving skills.
- Proficiency in both written and spoken English.
- Proficiency in computer skills, including Word Processing, Spreadsheet, and Database management applications.
- Experience in Submissions of Clinical Trials in CTIS according to CTR.
Global Life Science Hub is a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical, and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com or reach out to us via:
- Tel: +44 (0) 204 599 8130
- Email: email@example.com