CLINICAL PROJECT MANAGER / DIRECTOR
Job type: Full time
Report to: VP or Director, Clinical Affairs
Clinical Venture Services Ltd provides clinical study support services to the medical device community with a specialist interest in early and late phase start-up med-tech and bio-tech industries. Currently the preferred clinical partner for ReCor Medical Inc. a US-based subsidiary of Otsuka Medical Devices, exploring device-based therapies for hypertension, we are recruiting for an experienced clinical project manager/director preferably based at the Sandwich office. The ideal candidate would have expertise in leadership of the design, implementation and execution of global clinical studies in collaboration with Regulatory, Scientific Affairs, Research and Quality partners. This senior level clinical project management position requires a unique combination of leadership and execution abilities. Ability to execute quality global clinical trials in accordance with projected timelines and budgets is essential. Cross-functional team player, flexible, organized and motivated
- Develop and execute clinical studies in line with corporate requirements including appropriate planning, timelines and budget
- Leadership and direction of team of clinical support personnel including CRA and in-house support
- Cross-functional communication and planning including scientific affairs; regulatory; safety and marketing
- Design, development and submission of clinical study protocols in compliance with GCP; ISO 14155; FDA and other applicable International Regulatory authorities
- Ability and willingness to directly interface, including face-to-face with key regulatory agencies (FDA, BSI etc.) at all levels including study design submission and audit.
- Lead in the selection and oversight of clinical vendors and CROs as required to ensure appropriate study support and timelines are met
- Evaluation, development and initiation of clinical centers in collaboration with field based personnel, including center evaluation, facilitation of study approval process and preparation for patient enrollment.
- Understand and facilitate recruitment strategies at clinical sites in line with local needs.
- Guarantee highest level of Quality throughout the clinical process. Ensure protocol compliance, facilitation of data collection and source document verification and compliance with all applicable clinical trial regulations. Continuously evaluate, recommend and implement quality improvements at all levels as needed.
- Active influencer for product and process development through input to the corporation relating to product performance, procedural gaps or system-related improvements. Based on their extensive clinical experience, the project manager/director may directly influence the direction of the company with respect to clinical trial strategy and/or product developments.
- Ability and willingness to assist in the creation of study-specific clinical processes and reporting
Skills and Requirements
- Educated to a minimum of degree level (e.g. Biomedical Engineering; Life Sciences, Nursing). Supplemental graduate degree (MSc; PhD, MD) preferred.
- Substantial experience of all phases of global clinical trial and regulatory process including understanding of FDA; ICH and ISO 14155 regulations
- Prior experience in cardiology, electrophysiology, and cardiovascular and/or implantable cardiovascular device industry experience of 6+ years required
- Experience with Clinical trial budget development and tracking
- Experience with project management software (MS Project or equivalent) preferred
- Demonstrated ability to lead an interdisciplinary team including those located remotely and within external service providers. Willingness to personally provide multifunctional support across all aspects of clinical trial execution
- Strong organization skills, independent and proactive personality; able to think critically in stressful situations.
- Attention to Quality. Ability to effectively highlight and communicate quality related issues in a timely manner essential. SOP and process development and implementation required
- Strong communication, interpersonal and problem solving skills.
- Understanding of KOL development and physician customer relationships; importance of account management and business development key while ensuring appropriate clinical quality
- Self-motivated with excellent time management skills. Ability to work effectively with minimum supervision essential
- Computer literate with a working knowledge of Word, Excel, PowerPoint & Outlook
- Enthusiastic, positive and professional team player
- Fluent in English with additional language skills (French; German) preferred
- Willingness to travel as required by clinical workload. Expected travel for the current position is approximately 10-20%
- Competitive Salary dependent on experience
- Discovery Park gym membership (if applicable)
Interested applicants should send a cover letter and copy of their CV to Clinvenservices@recormedical.com or contact Helen Reeve-Stoffer on +44 (0) 1304 806862