Senior Clinical Project Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Deliver project strategy, management, and proactive planning for one or more highly intricate clinical projects.

• Ensure the safety and efficacy of BALT and affiliate products.

• Supervise contractors, vendors, and project team members to ensure timely and budget-compliant delivery of project outcomes.

• Manage and coordinate one or more clinical trials.

• Maintain trials in an audit-ready state, encompassing training records, central files, and system validation.

• Lead clinical study audits and mock audits involving regulatory authorities.

• Ensure that project deliverables and milestones are met across various projects.

• Communicate effectively with the Clinical Project Team, functional management, and BALT leadership.

• Develop and oversee projects within approved budgets and timelines.

• Assist in the selection, contracting, coordination, and management of CROs, vendors, and contractors.

• Create study manuals, study tools, and operational plans.

• Compile proposed investigational site lists and engage in site review and approval.

• Travel to investigational sites to foster clinical relationships and enhance collaboration.

• Collaborate with the supply chain to forecast required devices.

• Organize and attend investigator and coordinator meetings.

• Prepare and present clinical project status updates to Clinical Management.

• Manage corrective action plans at individual sites and throughout trials.

• Engage in both internal and external trial-related audits.

• Mentor and train team members, offering best practices.

• Participate in process and procedure teams unrelated to trials.

⛳️ Requirements

• Bachelor's degree required.

• A degree in a science or health-related field is preferred, such as Biology, Nursing, Biomedical, Pharmacy, or Veterinary Sciences.

• Over 8 years of experience in clinical/scientific research, nursing, or clinical trials related to medical devices/pharmaceuticals.

• Capability to independently manage multiple global complex clinical projects.

• Proficiency in analyzing diverse information and collecting research data.

• Ability to generate innovative solutions while maintaining attention to detail.

• Skill in gathering and analyzing information to develop alternative solutions.

• Adaptability to changes, management of competing demands, and handling unexpected events.

• Self-motivated, persistent, and capable of overcoming challenges.

• Strong oral and written communication skills, including effective data presentation and engagement with senior leadership.

• Capability to build interpersonal relationships with medical professionals.

• Comprehensive knowledge of clinical research conduct, laws, regulations, standards, and relevant BALT SOPs and policies.

• Ability to perform light lifting, engage in moderate computer usage, and sustain prolonged periods of sitting or standing.

• Approximately 20% domestic/international travel required.

🏝️ Benefits

• Engage in meaningful work that enhances patient lives.

• Join a close-knit, mission-driven team.

• Receive recognition for your contributions and respect for your work.

• Be part of a multicultural community.

• Enjoy travel opportunities to investigational sites, conferences, and both domestic and international locations.