[Hiring] Sr. Clinical Project Manager @Balt Group

Role Description

Experienced professional who provides project strategy, management, and displays a proactive approach to plan, prepare and execute one (or more) highly complex quality clinical project(s) to ensure safety and effectiveness of BALT and BALT’s affiliates products. Provides oversight for contractors/vendors and project team members toward completion of deliverables in a timely fashion within agreed project timelines and budget. Interfaces with all study functions and site investigators and clinical site staff.

Job Responsibilities:

• Responsible and accountable for the management and coordination of one or more clinical trial(s).
• Ensures 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.
• Assigned to other non-trial related activities such as process and procedure teams.

Qualifications

• 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.

Requirements

• Bachelor’s-level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical, Pharmacy or Veterinary Sciences) preferred.
• 8+ years’ experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials.

Physical Requirements

• Light lifting.
• Moderate computer usage.
• Extended periods of sitting or standing.
• ~20% domestic/international travel.

Work Environment

• May be remote with occasional requirements to travel to Balt and/or clinical research sites and/or conferences.
• Working conditions are normal for an office environment.

Company Description