Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Leads the management, coordination and evaluation of medical projects for one or more programs in collaboration with management and other stakeholders to ensure consistency, alignment, and compliance of internal processes as well as optimal performance and issue resolution throughout project lifecycle. Represents the company in the medical research community and proactively liaises with clients to ensure optimal performance and utilization of medical project team(s).

Essential Functions:

• Works independently to perform and/or lead first pass review of safety data utilizing line listings, company dashboard(s), and/or other visualization tools. Reviews data for safety trends, coding consistencies, and potential follow up with investigator sites. Proactively identifies any potential issues and resolves or escalates as appropriate.
• Reviews safety data and provides comprehensive summations for safety review meetings. Reviews designated sections of aggregate reports.
• Initiates and leads initiatives to improve current processes and develops new processes regarding medical monitoring and department services. May develop guidance documents and assists with the implementation and/or revision of corporate level documents such as SOP's and WPD's.
• 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 as applicable. Serves as the primary point of contact for clinical project teams on studies and can act as the alliance level lead on larger alliance/multi-protocol studies.
• Creates and maintains safety and medical management plan(s) on studies (as applicable) and ensures that the processes included in the plan document are reflective of the contract and services requested for studies that have department involvement as well as standalone studies (ex. MM and/or MPC).
• Works independently to monitor the 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 can attend risk management meetings to discuss.
• Presents at business development, client, and investigator meetings and participates in strategy/business development calls. Represents studies at risk management meetings.
• Independently determines hours required for out of scope work for both the MM and MPC and provides this to the finance/study team for contract modifications. Attends meetings to discuss/justify the modification requirements.
• Trains and develops new team members. Serves as main point of contact for team member questions with escalation to management as appropriate. May provide input on individual performance to direct line manager. Organizes and leads meetings with team members to discuss potential process issues, answer questions, and brainstorm ideas and solutions.
• Resolves complex problems through in-depth evaluation of various factors and offers solutions.

• Superior knowledge of GCPs for medical oversight of clinical trials
• Advanced Knowledge of drug development and safety reporting
• Advanced Knowledge of safety data trending to include coding
• Advanced knowledge of biostatistics, data management and clinical procedures
• Exceptional problem solving and critical thinking skills
• Exceptional project management and budget skills
• Excellent mentoring skills and ability to train and lead others
• Exceptional oral and written communication skills
• Provides outstanding attention to detail
• Ability to work in a collaborative team environment
• Ability to maintain a positive and professional demeanor in challenging circumstances