Sr. Clinical Project Manager

Balt is hiring a Senior Clinical Project Manager to plan and manage complex clinical projects supporting the safety and effectiveness of its products. The role oversees trial teams, vendors, budgets, timelines, audits, and clinical-site relationships.

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