Clinical Project Manager - United Kingdom
This position is responsible for managing the Company’s clinical projects, post-market surveillance and associated clinical marketing activities.
This position will support the development of a global clinical strategy and manage the timely execution of clinical projects and post-market surveillance activities, and is a significant management role with high visibility within the business. The Clinical Project Manager will provide project management expertise throughout the development, implementation and execution of clinical studies, and provide expertise into cross-functional teams to support the delivery of clinical marketing, education and commercialization objectives. The individual will have significant interaction with CROs, distributors and clinicians and must have strong interpersonal and communications skills to develop close, productive relationships. Must be highly self-motivated, organized, able to work collaboratively and execute with attention to detail in accordance with ICH/GCP guidelines.
Specific Functions and Responsibilities:
- Design, plan and implement clinical research projects in accordance with regional (e.g. EU, FDA) and ICH-GCP requirements.
- Manage all clinical study project elements from initiation to close-out.
- Develop protocols, monitoring plans, case report forms, informed consents, study manuals and study budgets.
- Negotiate contracts and budgets with CRO and related third party vendors and CRAs.
- Negotiate site contracts and budgets, and perform site visits at all stages throughout the clinical study.
- Work collaboratively with CRO to manage and execute the clinical strategic operations plan for projects including timelines, resources and cost.
- Review and/or submission of research ethics committee/regulatory documentation.
- Prepare Clinical Study Reports and safety reports.
- Manage existing and planned post-market surveillance activities and provide annual reports to meet regulatory requirements (EU).
- Prepare Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP) reports.
- Review monitoring activities and reporting for accuracy, completeness and conformance with SOPs.
- Maintain frequent contact with internal stakeholders and work effectively with study investigators and coordinators.
- Assist with the training and education of study sites and key opinion leaders.
- Develop clinical performance metrics and establish reporting frequency.
- Support the development and implementation of clinical downstream marketing tools.
- Consult with cross-functional teams to develop product launch plans.
- Support the commercial team from a clinical perspective.
- Perform other reasonably related activities as requested.
Education or Formal Training Required:
- Bachelor’s Degree (B.S. or B.A.)
- Five to ten years experience in medical device clinical study management, preferably involving Class III products.
- Two to five years of post-market surveillance management and implementation.
- Detailed knowledge of medical device clinical evaluation in accordance with EU requirements.
- Knowledge and awareness of medical device clinical evaluation in accordance with USA FDA requirements.
- Competency in ICH-GCP and a strong interest in clinical research.
- Ability to build and manage a dynamic clinical strategy and expedite project delivery.
- Monitoring experience and/or co-monitoring experience is required.
- Highly organized, self-motivated and with strong abilities to analyze and resolve problems.
- Exceptional communication skills. Must be able to effectively communicate (both verbally and in writing) in individual and group situations.
- Must be able to make objective and subjective decisions and use judgment in non-routine situations.
- Must have strong ability to plan, prioritize and execute.
- Must be creative, identify opportunities for improvement and maintain high standards for deliverables.
- Must be able to work effectively with cross-functional teams and external sub-contractors.
- Must be self-motivated, assertive and able to approach with a positive ‘can-do’ attitude.
- Computer literate with knowledge of Microsoft Word, Excel, and Outlook.
Extent of Supervision:
- Minimal supervision and guidance.
- Self-reliant; takes initiative; results-oriented, open minded.
- A wide degree of latitude is expected.
- Combines analytical approach with experience and judgment to plan and accomplish goals.
We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.