Medical Project Manager

Employment Type: Full time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office Location Type: [Not Specified] Salary: [Not Specified]

Position Overview

Manages, coordinates, and evaluates medical projects for one or more programs in collaboration with management and other stakeholders. Ensures consistency, alignment, and compliance of internal processes, as well as optimal performance and issue resolution throughout the project lifecycle. Represents the company in the medical research community and develops collaborative relationships with client company personnel.

Essential Functions

• Safety Data Review:
  • Independently performs first-pass review of safety data using line listings, company dashboards, and/or other visualization tools.
  • Reviews data for safety trends, coding consistencies, and potential follow-up with investigator sites.
  • Proactively identifies potential issues and resolves or escalates them as appropriate.
  • Reviews safety data and provides summations for safety review meetings.
  • Reviews designated sections of aggregate reports.
• Project Leadership:
  • Independently functions as the Project Lead for medical monitoring services when SAE case processing has not been contracted.
  • Manages project implementation, coordination, maintenance, and close-out of assigned studies.
  • Serves as the primary point of contact for clinical project teams on studies.
  • Can act as the alliance-level lead on larger alliance/multi-protocol studies.
• Medical Management Plan:
  • Creates and maintains medical management plans on studies as applicable.
  • Ensures processes in the plan document reflect the contract and services requested for studies with department involvement and standalone studies (e.g., MM and/or MPC).
• Financial and Operational Management:
  • Independently monitors project financial status, unit forecasting, actual realization, and team allocations in systems.
  • Coordinates staff projections based on contract values and actual hours used.
  • Escalates any financial and/or operational risks and attends risk management meetings for discussion.
• Scope Management and Modifications:
  • Independently determines hours required for out-of-scope work for teams.
  • Provides out-of-scope work information to finance/study teams for contract modifications.
  • Attends meetings to discuss and justify modification requirements.
• Problem Resolution and Mentoring:
  • Resolves complex problems through in-depth evaluation of various factors and offers solutions.
  • May assist management in training and mentoring.
• Client and Business Development:
  • Presents at business development, client, and investigator meetings.
  • Participates in strategy/business development calls.
  • Represents studies at risk management meetings.

Qualifications

• Education and Experience:
  • Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN.
  • Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
  • Includes 5+ years of clinical safety experience (clinical research monitoring, pharmacovigilance, or a combination).
• Knowledge, Skills, and Abilities:
  • Advanced knowledge of GCPs for medical oversight of clinical trials.
  • Knowledge of drug development and safety reporting.
  • Advanced knowledge of safety data trending, including coding.
  • Working knowledge of biostatistics, data management, and clinical procedures.
  • Excellent problem-solving and critical thinking skills.
  • Excellent project management and budget skills.
  • Effective mentoring skills and ability to train and lead others.
  • Strong oral and written communication skills.
  • Strong attention to detail.
  • Ability to work in a collaborative team environment.
  • Ability to maintain a positive and professional demeanor in challenging circumstances.

Management Role

• No management responsibility.

Working Conditions and Environment

• Work is performed in an office, laboratory, and/or clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal Protective Equipment (PPE) may be required.