What are the responsibilities and job description for the Senior Clinical Trial Manager position at ALPFA Medical?
The Senior Clinical Trial Manager will be responsible for the planning, execution, and oversight of clinical studies in support of the company’s medical device development programs. This role will manage day-to-day clinical operations activities, ensuring compliance with GCP, ISO 14155, and regulatory requirements, while collaborating cross-functionally with Clinical, Regulatory, Quality, and R&D teams.
The ideal candidate is a hands-on, proactive clinical operations leader who thrives in an early-stage environment and can balance strategic oversight with operational execution.
Responsibilities
- Lead the operational planning, initiation, and conduct of clinical studies (from feasibility through post-market).
- Oversee CROs, vendors, and study sites to ensure timely delivery of high-quality clinical data.
- Develop and manage study documents, including protocols, informed consent forms, monitoring plans, and clinical reports.
- Ensure clinical trial activities are conducted in compliance with GCP, ISO 14155, local regulations, and company SOPs.
- Oversee site qualification, initiation, monitoring, and close-out activities.
- Collaborate with Clinical Development, Regulatory, and Quality teams to ensure study design and execution meet strategic objectives.
- Manage study timelines, budgets, and resource allocation; proactively identify risks and mitigation strategies.
- Serve as primary point of contact for CROs, investigators, and internal stakeholders.
- Support preparation for regulatory submissions, audits, and inspections.
- Contribute to development of clinical SOPs, tools, and processes to support a growing clinical organization.
Qualifications
- Bachelor’s degree in life sciences, nursing, or related field; advanced degree preferred.
- 8 years of experience in clinical research, with at least 3 years managing medical device clinical studies (Class II/III or implantable preferred).
- Strong understanding of GCP, ISO 14155, and applicable FDA and MDR regulations.
- Experience managing global clinical trials and working with CROs and vendors.
- Proven ability to manage multiple projects in a fast-paced, start-up environment.
- Excellent organizational, problem-solving, and communication skills.
- Willingness to travel domestically and internationally (up to 15%).