Senior Clinical Trial Manager
**This position requires being onsite in San Diego. Please DO NOT apply if you want a remote only role. We are looking for local candidates or someone who is open to relocating to sunny San Diego**
This is an exciting time to join a clinical-stage cell therapy/regenerative medicine biotech company that is growing quickly!
- Ability to effectively manage day-to-day overall operations of multiple clinical trials independently and mentor junior CTMs.
- Lead, organize, assign, and track tasks assigned to clinical team members (e.g., consultants or in-house team) on assigned studies.
- Lead individual clinical trial team meetings for assigned studies.
- Drive timely enrollment of trial participants for assigned studies.
- Ensure creation of key study documents (e.g. informed consent document, case report forms, monitoring plan, and clinical study reports) via oversight of assigned team members and through directly authoring as needed
- Establish and maintain assigned trial timelines to ensure alignment with the Clinical Development Plan.
- Ensure implementation of internal procedures to support ICH and GCP adherence on assigned clinical trial(s).
- Create and track assigned study budget(s) to ensure spend remains within target.
Skills and Requirements:
- Bachelor's degree and a minimum of six years of relevant clinical research experience are required. A degree in the life sciences is preferred.
- Working knowledge of Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, ICH Guidelines, and other regulatory requirements is required.
- Familiarity with diabetes, metabolic disease, cell therapy, and/or cutting edge translational medicine is strongly desired.
- Must possess several competencies, including diligence, self-initiative, an ability to effectively convey information, and a predisposition for being highly organized.
- Must have strong interpersonal skills including the ability to work with different personalities and styles, moderate and mediate, build and maintain consensus, and turn work assignments into value-added actions.
If you are having difficulty in applying or if you have any questions, please contact Jax Zafrani at (+1) 213-893-4997 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.