Study Start-Up Manager - Paris, France-148529

Europe, Middle East & Africa-France-Île-de-France
On Application
02 Oct 2018
11 Jan 2019
Come develop your career with PPD.

As a result of the newly formed Site Patient & Access (SPA) group in PPD, there is currently a vacancy for a Study Start Up Manager position to manage part of the SPA Country team in France

Previous project management experience is essential to be considered for this role.

You will be reporting to a Director or Associate Director SPA EMEA, and hold the following responsibilities:


• Line management, selection, training, coaching and performance management of Project Assistants, Country Approval Specialist, Clinical Research Associates, Contract Specialists who are part of the SPA country team

• Leadership and management of SPA staff for France

• Focus on client's expectation for all start-up deliverables, timelines and quality

• Acts as point of contact for information and escalation for issues/risks related to the assigned country and for SIA stakeholders e.g. CTM, PM, BD, Regulatory Department, local sponsors affiliates and Clinical Management team

• Liaise with Contract Managers, Regulatory Specialists and other key site activation stakeholders to ensure technical risks and issues are properly routed and resolved and to confirm local hires reflect the necessary technical skills and experience

• Provide local leadership for the execution of site activation activities

• Responsible and accountable for oversight and delivery of site intelligence related activities, e.g., strategic feasibility, strategic investigator relationships etc.

• Liaise with STM role to ensure proper alignment with global operating model and operational escalations to internal and external customers.

• Focusing on end results to be achieved, uses metrics and key performance indicators to manage individual and team performance

• Provide input into audit reports with findings related to site activation, including CAPA implementation into audit reports with findings related to site activation



Minimum Required Education and Experience:

•    Bachelor's Degree in Health Sciences preferred or licensed or certified health care training (e.g.: RN, MT, PA, RPh,)
•    Significant clinical research experience (comparable to 5 years) including one of or a combination of; clinical management, regulatory, contract management, study management and start-up
•    Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities
•    Valid Passport

The following qualifications are expected from the candidate:  
Required Knowledge, Skills and Abilities:
•    Demonstrate leadership of the country team, ensuring PPD core competencies are maintained and enhanced
•    Demonstrate effective mentoring ability including excellent interpersonal skills
•    Ability to manage a cross functional team of professionals who may have expertise in a different areas of clinical research
•    Demonstrate understanding of the ability to learn and demonstrate understanding of PPD SOPs, WPDs, and relevant regulations e.g. ICH/GCP, FDA guidelines)
•    Demonstrate ability to evaluate medical research data and demonstrate proficient knowledge of medical terminology
•    Effective organizational and negotiation skills
•    Strong attention to detail
•    Effective written and oral communication skills
•    Good knowledge of English language and grammar
•    Competent use of computer to include data entry, archival and retrieval
•    Ability to travel as needed
•    Excellent team player with team building skills
•    Excellent interpersonal and conflict resolution skills
•    Utilize problem-solving techniques applicable to constantly changing environment
•    Proficient knowledge of medical/therapeutic areas and medical terminology

If you are interested in this position and wish to be part of our global team of professionals, please apply today with your C.V

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.


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