Essential Function:
Provide overall management of clinical trials or clinical studies
General areas of responsibility include: Sponsor liaison, project assessment and initiation, resource procurement and planning, project implementation, leading and motivating a cross-functional team, milestone planning and tracking, ensuring that projects are progressing according to contract and quality standards, SOPs, GCP and/or other guidelines to fulfill local regulations, production of key project progress reports, management of communication between AXIS project team, Sponsor, contract and financial management
Relationships:
Reports to: Director, Vice President
Directly supervises: CRAs
Provides work direction to: CRAs
Works closely with: All internal departments
External relationships: Clients, Subcontractors, Vendors
Responsibilities:
Sponsor Liaison:
o Take primary responsibility for sponsor relationship and sponsor communication ensuring high Sponsor satisfaction.
Project Initiation and Planning:
o Organize a meeting with Account Management to understand the scope of the contract and any Master Services agreement in place for the sponsor
o Review the project contract exhibit and send it for information to the Functions involved in the project or make sure that the Functions have received it from another source and request Functional Lead (FL) resources from appropriate functional heads
o Develop a project plan, including all elements listed in the project plan template as appropriate for the project (roles and responsibilities, communication plan, risk analysis, etc).
o Review initial budget split provided by contracts, request for study specific adaptations and develop Revenue Recognition Tool for the project
o Call sponsor to understand scope of work
o Call the team kick-off meeting, inviting FLs or a representative from each functional area involved, ensure the scope of the study is well understood by all functions and that the appropriate resorting will be delivered by the functions
o Facilitate the discussion of Sponsor and FLs concerning study/ sponsor specific metrics and how these can be collected
o Ensure that study specific management tools and Central File Maintenance plan are set up
o Provide or arrange for project-related training as needed for team members
o Initiate the project following best practices in project management
Project Implementation, Control and Evaluation
o Ensure the project is completed within budget, schedule and according to contract specifications
o Ensure the project is progressing according to quality standards, SOPs, GCP and/ or other guidelines to fulfill local regulations
o Ensure information entered into management systems is accurate and updated on a regular basis
o Use project plan as a management tool to record and measure progress, updating as necessary
o Gather feedback from FLs on deviations of metric collection and on action taken.
o Gather feedback from FLs to evaluate the project progress and profitability or determine with the FL the cause of project overruns and comment on their corrective actions
o Hold team meetings on a regular basis to responsibilities of team members; monitor the progress of each individual project deliverable against project plan and budget. Assessing the overall status of the project.
o Resource allocations for next project deliverables
o Hold end of phase meetings to review lessons learned
o Take primary responsibility for the response to project audit findings specific to the project
o Manage the budget including the completion of monthly revenue recognition with the Finance Department, forecasting and cost management
o Manage the project proactively, anticipating problems and providing resolutions in a timely manner.
Communication
o Serve as primary contact for the Sponsor
o Ensure the communication to team members of the scope of work, timeline and project goals, technical information, and input from Sponsor throughout the project
o Ensure the communication to the Sponsor of timeline and project progress, the results of risk analyses, contingency plans, technical information, and input from team throughout the project. Also, any significant changes in resourcing, scope of work and timelines
o Inform team members of any new information or modification of project-related issues that may affect specific responsibilities of team members
o Report to appropriate Line Managers any anticipated need for addition or re-assignment of FL resources
o Communicate to Line Manager any needs or concerns regarding level of training or performance of FL
o Provide Line Manager with input regarding team members’ performance as needed for employees’ periodic performance review
o Communicate with Finance Department
o Prepare project plans, project status and other administrative reports and submit to Sponsors as required by the contract exhibit, and other internal stakeholders
o Communicate fiscal, contractual, resource, deliverable and Sponsor-related issues to Line Manager, as appropriate
Project Closeout
o Ensure all administrative closeout procedures are completed, according to Project Closeout Checklist
o Ensure project is archived and all documentation returned to sponsor as specified the by the contract
o Hold end of study meeting ensure lessons learned information is documented and passed on via appropriate channels
Skills
Excellent interpersonal, site management and relationship building, verbal and written communication skills including excellent presentation skills at conferences, meetings, training sessions
Demonstrated ability to manage and motivate direct reports
Team player with outstanding negotiation and organizational skills
Client focused approach to work
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
IT literate (experience with Microsoft based applications and general knowledge of PC functions)
Able to take initiative and work independently
Sense of urgency in completing assigned tasks
Education:
Educated to Master’s degree level (biological/ life science, pharmacy or other health related discipline preferred)
Language Skills:
Competent in written and oral English
Minimum Relevant Work Experience:
7+ year of clinical research experience with a pharmaceutical, CRO, or device company or similar experience
Prior management experience preferred
Physical Requirements:
Ability to travel as needed
