Sr. Clinical Project Manager

Balt is hiring a Senior Clinical Project Manager to provide strategy and manage complex clinical projects that support the safety and effectiveness of its products. The role oversees trials, teams, vendors, budgets, timelines, audit readiness, and communication with clinical sites and leadership.

Responsibilities:

• Responsible and accountable for the management and coordination of one or more clinical trial(s)
• Responsible for ensuring the trial is “audit ready” at any point in time (project team training records, central files, system validation, etc.). Serves as front-room lead for clinical study audits for mock audits and by regulatory authorities
• Leverages relationships, resources, senior-level expertise, and knowledge across multiple projects to ensure attainment of project deliverables and milestones
• Responsible for effective communication within the Clinical Project Team, with functional management, and Balt leadership. Relied upon as Clinical Operations subject matter expert
• Develops and manages the project(s) within the approved budgets and timelines
• Supports the selection process, contracting, coordination and management of the CROs/vendors/contractors contracted for a given project
• Responsible for ensuring development of clinical project deliverables such as study manuals, study tools, and operational plans
• Compiles proposed investigational site lists and participates in reviewing and approving investigational sites
• Travel to investigational sites to build clinical relationships and improve collaboration
• Directs forecasting of devices necessary for project in collaboration with supply-chain
• Supports the coordination and attends investigator and coordinator meetings, representing the clinical project team
• Prepares and presents the status of the clinical project(s) to the Clinical Management
• Responsible for corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits
• Demonstrates thorough knowledge in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BALT SOPs and policies
• Mentors and trains team members and provides best practices
• Is also assigned to other non-trial related activities such as process and procedure teams

Requirements:

• Analytical - Ability to support analysis of diverse information; collects research data; uses results and experience to inform the appropriate functions regarding product specific direction (as appropriate)
• Design - Generates creative solutions; demonstrates attention to detail
• Problem Solving - Gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations
• Organizational Support - Supports organization's goals and values
• Adaptability & Dependability - Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events. Takes responsibility for own actions; keeps commitments
• Innovation - Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas
• Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence. Independently motivated
• Demonstrated ability to independently manage multiple global complex clinical projects
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds clearly to questions. Ability to develop good interpersonal relationships with medical professionals. Good presentation skills. Comfortable addressing senior leadership
• Written Communication - Writes clearly and informatively; presents data effectively and accurately. Communicates effectively and persuasively
• Bachelor's-level degree required
• 8+ years' experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials
• Degree in science/health related field (e.g., Biology, Nursing, Biomedical, Pharmacy or Veterinary Sciences) preferred