Associate Manager Clinical Operations, FSP

United Kingdom
16 Apr 2021
06 May 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

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.Qualifications

• 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.

• 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).Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

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