MedFocus Clin. Project Leader-INSTAFF in United States

Job Description: Summary: The primary role of the Clinical Project Leader (CPL), is to act as the key operational interface with internal and external services to develop, implement, maintain and improve operational processes for US clinical trial conduct. This position supports the US CRU Clinical Investigators, medical advisor (MA), in the conduct and management of clinical trials in the US. Supervises in-house Clinical Research Associates (CRA’s), Clinical Project Assistants (CPA’s), contract CRA’s, and coordinates activities of Regional CRA’s for US clinical trials with awareness of related functions and roles. Significant operational planning and analysis is required.

Duties: 1. Responsible for the overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s) in the US. 2. Interface with corporate CTMs, Regional CRA Team, MAs and CSDs for operational input for feasibility, trial design/methodology, standard US medical practice and data capture. 3. Develop and manage the US trial budget. Overall responsibility for negotiation of financial aspects of clinical trial. 4. Collaborate with medical function in the safety evaluation of study subjects in ongoing trials. 5. Ensure all aspects of study site management i.e. recruitment of qualified investigators, site initiations, conduct investigator meetings for US only studies, ensure enrollment criteria are met and other aspects of the study management as appropriate. 6. Management responsibility of in-house CRAs and CPA’s. Responsible for mentoring and team cohesion. CPL mentoring as needed. 7. Facilitate development of study tools and appropriate tracking systems for coordination of trials, grants, enrollment status and clinical supplies. Ensures adherence to contractual obligations of local vendor relative to the service provided, as appropriate. Contribute to operational details in specifications for local vendor contracts, as needed. Challenges:

  • Fulfillment of project timelines and patient accrual goals is primary goal/challenge. Motivating team effectiveness and communicating with Regional Teams and Management Teams is also high priority goal. [Partnering, mentoring, overseeing, responding proactively will aid in problem solving] Internal and External Relationships:

  • Internal: Project team members (daily) Regional Staff, Clinical Trial Team, MA, ICTM, CDM, CQ&C; and other functional areas (as needed)

  • External: Clinical study site personnel, vendors (as needed) Decision Making:

  • Operational planning and oversight for project involves broad decision-making responsibilities.

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Job Requirements: Knowledge and Skills:

  • Working knowledge of clinical study development, FDA regulations and ICH/GCP guidelines.

  • Operational planning experience.

  • Excellent interpersonal and communication skills (verbal and written), including proficiency in medical terminology.

  • Professional demeanor with ability to interact effectively with scientists and managers from multiple disciplines; serves to provide internal operational expertise on assigned area and liaise with external organizations specific to clinical trial.

  • Strong organizational and time management skills.

  • Self-motivation and attention to detail.

  • Proficient with computer systems, or willingness to learn. Education and Experience:

  • CPL-Bachelor’s degree and 8+ years of clinical research experience.

  • 1-2 years of field monitoring experience.

  • Prior demonstration of an ability to manage people and projects.

Min Salary: $0.00

Max Salary: $0.00