Director of Clinical Trial Operations
# of Openings:
Director, Clinical Trial Operations
In this position the Director, Clinical Trial Operations will play a key role in supporting the design, managing the implementation and conduct of the next stage of state-of-the-art clinical utility prospective multi center trial(s) and registries across a number of continents that may help change the standard of care and improve patient outcomes in transplantation. The candidate will provide direction and operational leadership of the clinical research studies to ensure delivery on time, within budget, and of high-quality in compliance with ICH GCP, Internal SOPs and all other applicable regulations.
The Dir, CTO should be a critical thinker and capable of problem solving and aligning the priorities with study outcomes and timelines as well as be proactive and unafraid to get their hands dirty. A good candidate should demonstrate clinical development experience of the operational aspects of all stages of clinical studies preferably working in and/or monitoring or leading affiliate teams, working with vendors and/or CROs, study supply management and planning operational activities to achieve database lock. A knowledge of molecular diagnostics and regulation associated with this space across multiple continents is an essential component of this role.
Interaction with Clinical Sites
- Attend to procedures to support sites (e.g. provide guidance on case report form [CRF] completion)
- Collect data/observations and obtain product development feedback.
- Interact directly with clinical sites, including clinical investigators and other health care professionals involved in the clinical study
- Conduct site visits (e.g., site selection visits, pre-study site visits, training visits, site initiation visits, interim site visits, and study close-out visits), as required.
- Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
- Develops and maintains effective working relationships with multiple teams, external CRO (for outsourced teams) and co-development partner study teams.
- In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to team members.
- Oversees the development and maintenance of study specific manuals.
- Contributes to the development and management of the study timelines, resources, budget, risk and quality plans.
- Contributes to study management of new and ongoing studies.
- Establishes study milestones and ensures accurate tracking and reporting of study metrics.
- Ensures operational tracking tools are identified, including systems to meet the needs of the operations team.
- Provides operational input into the development of protocol feasibility questionnaires.
- Act as a liaison directly between our company and clinical sites.
- Generate clear and concise trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.) and clinical summaries.
- Maintain study documentation (e.g., correspondence, CRFs, deviations, budget information).
- Serve as a clinical resource to other departments at our company to support product design, development and marketing efforts.
- Monitor activities at clinical study sites to ensure compliance with Good Clinical Practices (GCPs), IDE, SOPs, and study protocols.
- Assist in generation of protocols, CRFs, Informed Consent documents, Instructions for Use Manuals, and site training materials for pre- and post-market studies.
- Ensure clinical studies are conducted in a timely manner and within site budgets.
- Assist in preparation of reports for submission to regulatory agencies.
- Develops and manages clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans.
- Communicates variances in the budget and action plan for resolution.
- In collaboration with the Medical Director, assist in building effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
- Creates team culture and promotes team spirit. Able to lead and be led.
- Degree in life sciences, health sciences or equivalent degree/experience (e.g., BS, MS, PharmD, PhD)
- 3-5 years leading a team of direct reports in clinical trials and operations
- 5 years’ experience implementing and monitoring clinical studies preferably involving diagnostics tests.
- Proficient in FDA and cFDA regulations, as EU regulations and GDPR for clinical studies and medical devices, including GCPs.
- Working knowledge of medical terminology.
- Experience with medical laboratory testing and documentation of patient information.
- Comfortable with technology and scientific/engineering principles.
- Excellent knowledge of MS Word, PPT and good knowledge of MS Excel.
- Strong project management, documentation, and organizational skills
- Must be detail- and accuracy-oriented, precision is essential
- Must have high standards for quality of work and a strong work ethic.
- Strong verbal communication skills and effective writing skills as well as ability to present.
- Successful history in a team-oriented environment yet able to work independently.
- Must have a sense of urgency about problem-solving and completing projects.
Skills and Experience:
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in and/or monitoring or leading affiliate teams, working with vendors and/or CROs, study supply management and planning operational activities to achieve database lock.
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans.
- Good knowledge of ICH GCP Proven ability to successfully achieve results within a diverse team and in a fast-paced, high-intensity environment.
- Experience of working as part of a study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.
- Well-developed written and verbal communication skills demonstrated by ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.
- Experience with clinical studies involving organ transplantation.