Clinical Project Manager

The Project Manager assumes responsibility for an individual project, or many projects. As he/she is the liaison with the sponsor, the project manager communicates in an optimal way, making sure that specific sponsor objectives are met. The function of the Project Manager involves little people management and mainly focuses on the product development program and trials.

Qualifications

• Bachelor's degree in life science/related field, advanced degree preferred.
• Minimum of 5+ years in clinical research industry.
• Proven experience as a clinical project manager or similar role in the pharmaceutical, biotechnology, or medical device industry.
• In-depth knowledge of clinical research, EU regulations, and ICH/GCP guidelines.
• Strong leadership, organizational, and time management skills.
• Ability to make decisions involving conflicts of interest.
• Coordination and planning of budgets, people and time management.
• Problem solving at a strategic level, working with others to reach a resolution.
• Careful planning to achieve accurate and timely results.
  
  
  

Responsibilities

• Expert knowledge of and compliance with relevant international and local regulatory requirements.
• Identifies potential study problems, implements solutions, follows through to resolution and improves timelines. Proper and timely escalation of issues.
• Demonstrate proficiency in conducting all visit types, including accompanied visits for training/mentoring purposes.
• Excellent communication skills, including effective and appropriate interaction with the study team, site staff, other KlinEra departments, senior management (director level and above) and any external parties involved (sponsors, vendors and other third parties).
• Ability to facilitate team building, conflict resolution and negotiation as needed to promote productivity and the accomplishment of timelines.
• Ensure quality maintenance of study related files (both electronically and hardcopy)
• Development of high quality study-related documents, including, but not limited to, study-specific processes, newsletters, team training materials, and study status reports for client meetings
• Understanding the management of unit based contracts and profitable staff utilization/recovery according to the units within the contract for clinical services
• Provides effective and timely feedback to the CRA team as appropriate
• Effective negotiation of (or oversight of) Investigator site contracts and budgets, where applicable
• Demonstrate the ability to manage multi-service and/or cross-functional medium to large/complex projects in accordance with timelines and budgets.
• Actively participates in site payment runs and basic understanding regarding data input into tracking systems and analysis of site payments with supervision
• Participate in the hiring Clinical Operations personnel interview process and provide feedback as requested.
• Initiates Risk and Contingency Plans before risks arise and implements plans/triggers appropriately
• Exemplify expertise to prepare and handle audits (both internal/ external/ sponsor) &/or inspection and follow through till CAPA resolution.)
• Effectively manages staff through open, timely and regular feedback. Ensures individual and team achievements are appropriately recognized.
• Demonstrates thorough knowledge of tracking systems including analysis of data output for potential errors and study trends.
• Facilitate effective communication and collaboration among project team members, stakeholders, and sponsors.
• Lead and motivate project team members and influence them to take positive action and accountability for their assigned work.