Clinical Trial Operations Opportunities at Parexel
Clinical Trial Operations
FSP Operations Manager応募 求人ID 56582BR ロケーション ブカレスト, București 仕事内容
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. As the FSP Manager, you will oversee project team members (CRAs, CMAs, CTSs, other as appropriate) within a region or across multiple regions, to ensure the FSP deliverables are met.
This position can be based in Romania, Poland, Russia or Ukraine.
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.
•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.
Project Implementation, Control & Evaluation
•Provides leadership and direction to project team members at a regional or global level.
•Identifies, organizes and delivers FSP specific training in collaboration with FSP client counterparts and FSP Leadership.
•Provides performance feedback on team members.
•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.
•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.
•Prioritizes effectively and respond to urgent requests within team or from sponsor.
•Possesses cultural awareness if managing projects within a region or across multiple regions to virtually lead a working team.
•Ability to motivate both individually and collectively.
•Demonstrates appreciation and understanding of finance and budgeting issues.
•Accountability for all designated tasks.
•Excellent computer literacy.
•Able to travel as per project demands to perform co-visits, cover for CRAs/CMAs/CTSs/other team members' absence.
•Educated to degree level (biological sciences, pharmacy or other health related discipline preferred).
•Competent in written and oral English, as well as Romanian
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).