Associate Manager Clinical Operations, FSP

Parexel International Corporation

United Kingdom - Any Region - Home Based


The FSP Manager is responsible for coordinating clinical operations functional teams and their activities to execute clinical studies within a region or across multiple regions. Liaising closely with the FSP Director, Sr. Director or FSP Head to ensure that the FSP deliverables (timeline, quality, productivity) are met.

Key Accountabilities:

• Manages and oversees project team members (CRAs, CMAs, CTSs, other as appropriate) within a region or across multiple regions, to ensure the FSP deliverables are met.

Client Liaison:

• Serves as primary point of contact to project team members for project related tasks/issues/queries, within a region or across multiple regions.

• Serves as primary point of contact for client's counterpart (study manager, Lead CRA, Project Coordinator, Global Study Manager, etc.) within a region or across multiple regions.

• Effectively communicates with internal and external customers as well as third party vendors.

• Prioritizes effectively and timely responses to urgent requests from internal or external clients.

Project Initiation & Planning:

• Leads and manages the implementation of FSP studies.

• Manages FSP study start-up activities, where appropriate.

• Provides input to FSP specific project tools, PL project plan, Central File Maintenance Plan.

• Provides input to the format and content for FSP reports.

• Reviews and provides input into FSP specific patient recruitment plan and retention plan.

• Ensures all FSP team members have access to tools and documents and that all FSP documents are maintained, managed and coordinated as required.

• Establishes efficient/effective working relationships with other functional Leaders and coordinators within a region or across multiple geographies and projects within a given FSP

Develops study plans, tools and forms in partnership with FSP counterpart.

Project Implementation, Control & Evaluation

• Provides leadership and direction to project team members at a regional or global level.

• Identifies, organizes and delivers (where appropriate) FSP specific training in collaboration with FSP client counterparts and FSP Leadership.

• In conjunction with the FSP Director/Sr. Director/FSP Head, will provide input on resourcing needs and ongoing FTE adjustments, for the region/countries under oversight.

• Provides productivity targets to FSP Director/Sr. Director/FSP Head.

• Provides performance feedback on team members as appropriate.

• Addresses identified and escalated site issues to drive their closure.

• Early recognizes areas of potential problems and provides input to contingency plans.

• Monitors study timelines, patient recruitment, retention and data cleaning to ensure successful outcomes of the FSP.

• Maintains and assures quality of work generated and escalates and follows up as appropriate.

• Ensures appropriate handover between FSP CRA/CMA’s or other team members as applicable.

• Provides input to FSP Director/Sr. Director/FSP Head for any Revenue Recognition forecasts.

• Identifies changes in scope and liaises with FSP Director/Sr. Director/FSP Head for implementation.

• May be required to accompany team members on site as per FSP demands.

• May be required to perform report review for the CRAs/CMAs at the project team that oversees, at a regional or global level.

• Participates in relevant FSP investigator and team meetings.

• Prepares, participates and follows up on audits/inspections.

• Exchanges working knowledge and ensures compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL and FSP WSOPs, SOPs, Operational Guidelines, Work Instructions and FSP specific procedures.

• Maintains relationships and monitors performance of vendors subcontracted for FSP studies.QualificationsSkills:

• Interpersonal, verbal and written communication skills.

• Client focused approach to work.

• Decision making, problem solving and time management skills. A flexible attitude with respect to work assignments and new learning.

• Ability to effectively and proactively manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.

• Willingness to work in a matrix environment and to value the importance of teamwork

• Organizational, diplomacy and team leadership skills.

• Possesses negotiation, diplomacy, team leadership skills and organizational ability.

• Effectively communicates with internal and external customers as well as third party vendors.

• Problem solving capability through early identification.

• Demonstrates appreciation and understanding of finance and budgeting issues.

• Accountability for all designated tasks.

Education:

• Educated to degree level (biological sciences, pharmacy or other health related discipline preferred).

Language Skills:

• Competent in written and oral English.

Minimum Work Experience:

• Substantial experience in Clinical Research Monitoring.

• Clinical Leadership experience or Study Management experience.

• Experience in Client Management/Facing activities.

• Experience in Line Management (desirable).


2021-05-03 00:05:21


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