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Sr. Clinical Project Manager

Cary, NC 27513

Posted: 03/17/2023 Employment Type: Contract To Hire Job Category: Project Management Job Number: 548447 Is job remote?: Yes Country: United States

Job Description

This position contributes to the Company’s success through accountability for the day-to-day operations of one or more clinical trials commensurate with complexity, including trial start-up, conduct, monitoring, and closeout activities.  The incumbent will develop and implement initiatives aimed to ensure the successful and timely completion of the Company’s sponsored clinical trials.  Also, the incumbent will provide oversight and cross-functional leadership to achieve efficient and effective performance, as well as provide feedback and assistance to maintain project plans to ensure critical paths are followed.  Delivering projects on time and on budget, while meeting the highest quality standards to ensure the highest level of internal and external client satisfaction is also key to this position.

SUMMARY OF KEY RESPONSIBILITIES •    Provides input on the clinical study design, monitors trial progress, manages the project-level budget and oversees quality assurance, managing external vendors, data management, and ensuring that reporting activities are completed.
•    Directs site communication and clinical monitoring input related to product development.
•    Oversees vendor training for all clinical aspects of drug development.
•    Coordinates materials for clinical trials.
•    Validates site-specific regulatory documents for IND and BLA filing.
•    Tracks tasks performed by project team members.
•    Monitors vendor GCP audits.
•    Reviews and creates clinical monitoring SOPs, manages training, and provides a leadership role in the maintenance of clinical operations monitoring standards.
•    Provides guidance and resolves affecting issues with Project Managers; ensures that project-related business processes are conducive to superior performance.
•    Ensures compliance with vendor agreements and subcontracting relationships.
•    Performs other duties, as assigned.
REQUIRED QUALIFICATIONS AND SKILLS •    BS in a scientific or health-related field; RN preferred
•    Minimum of 6 years’ clinical trial experience, with at least 2 years in a global setting
•    Broad experience with all aspects of clinical monitoring and oversight of contracted resources
•    Strong knowledge of GCP, FDA and ICH guidelines and applicable regulations
•    At least 3 years’ project management experience leading trials, and at least 5 years of clinical research experience in the biotech, pharmaceutical or CRO arena
•    Experience in budget preparation and financial management
•    Ability to mentor, as well as build network and strategic partnerships
•    Skilled at developing and implementing creative solutions
•    Ability to work constructively and productively in a matrix environment
•    Sense of urgency, accountability, and sound operational understanding.  Highly self-motivated, with superior organizational, communication and management skills
•    Maintains competency in relevant therapeutic areas
•    Builds partnerships and a positive team-based culture, maintaining a positive, results-oriented work environment
•    Communicates with the Company’s Executive Management in a clear, open, balanced, and objective manner
•    Therapeutic knowledge in any of the following areas is desired:  neurology, sepsis, critical care, oncology, respiratory/pulmonary or anti-infectives
Up to 30%, both domestic and international, during the interim phase of trials
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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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