Sr. Clinical Project Manager
About The Position
Balt is seeking an experienced Sr. Clinical Project Manager to provide strategy and management for one or more highly complex clinical projects, ensuring the safety and effectiveness of Balt and affiliate products. The role proactively plans, prepares, and executes projects and oversees contractors, vendors, and project team members to deliver work on time and within agreed budgets. It interfaces with study functions, investigators, and clinical site staff, and serves as a Clinical Operations subject matter expert. The position may be remote, with occasional travel to Balt offices, clinical research sites, and conferences. Working conditions are normal for an office environment. The role involves approximately 20% domestic and international travel. The listed pay range is $150,000–$170,000 USD.
Requirements
- Bachelor’s-level degree required.
- At least 8 years of experience in clinical or scientific research, nursing, or medical-device or pharmaceutical clinical trials.
- Demonstrated ability to independently manage multiple global, complex clinical projects.
- Strong analytical, organizational, problem-solving, adaptability, dependability, innovation, and self-motivation skills.
- Strong oral communication and interpersonal skills, including the ability to develop relationships with medical professionals, give presentations, and address senior leadership.
- Strong written communication skills, including the ability to present data effectively and accurately.
Nice To Haves
- A degree in a science- or health-related field, such as Biology, Nursing, Biomedical, Pharmacy, or Veterinary Sciences.
Responsibilities
- Manage and coordinate one or more clinical trials and ensure trials remain audit-ready, including training records, central files, and system validation.
- Lead clinical study audits, including mock audits and audits by regulatory authorities; may also participate in other trial-related audits.
- Use relationships, resources, senior-level expertise, and knowledge across projects to achieve project deliverables and milestones.
- Communicate effectively with the Clinical Project Team, functional management, and Balt leadership; present project status to Clinical Management.
- Develop and manage projects within approved budgets and timelines.
- Support the selection, contracting, coordination, and management of CROs, vendors, and contractors.
- Ensure development of clinical project deliverables, including study manuals, study tools, and operational plans.
- Compile proposed investigational site lists and participate in reviewing and approving sites.
- Travel to investigational sites to build clinical relationships and improve collaboration.
- Forecast required project devices in collaboration with supply chain.
- Support and attend investigator and coordinator meetings, representing the clinical project team.
- Develop corrective action plans for individual sites and across trials.
- Apply clinical research practices, laws, regulations, standards, and applicable Balt SOPs and policies.
- Mentor and train team members and share best practices.
- Participate in non-trial activities, including process and procedure teams.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
