Job Description

Our Clinical Operations Manager FSP role can be located in Czech Republic, Hungary, Lithuania, Italy, Spain, Poland, Romania or Serbia

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:

Coordinates and oversees project team members (CRAs, iCRAs, 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.

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.

Addresses identified and escalated site issues to drive their closure.

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

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

Participates in relevant FSP investigator and team meetings.

Qualifications

Minimum Work Experience

Substantial experience in Clinical Research Monitoring.

Clinical Leadership experience or Study Management experience.

Experience in Client Management/Facing activities.

Skills

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.

Education

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

Language Skills

Competent in written and oral English.

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.