Project Mgr, Early Phase Oncology - Ivry-sur-Seine, France - Thermo Fisher Scientific

Thermo Fisher Scientific

Entreprise vérifiée

Ivry-sur-Seine, France

il y a 1 semaine

Posté par:

Sophie Dupont

beBee Recruiter

Description

Who is PPD?
PPD is a leading global contract research organization. Our purpose is to improve health. Our mission is to help customers deliver life-changing therapies. Our strategy is to bend the cost and time curve of drug development and optimize value for our customers.

The PPD FSP Solution:

PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions.

We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality.

We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Position summary:

Responsible for the operational planning, management and operational excellence in execution of clinical studies and program(s) with trial operations
Leads the crossfunctional Clinical Study Team driving innovation to deliver study objectives on time and within budget, to the highest quality standards

Responsibilities:

Develop, manage and revise the Study budget
Review and develop the Study Protocol and the SIS/ICF and any other required study tools
Responsible for Feasibility/Country Selection by developing Feasibility Questionnaire, contribute to process
Manage the study Risk and develop risk Mitigation Plan. Leading Study risk mitigation and contingency plan
Lead CST communication, reporting and stakeholder engagement
Review regular vendor status reports. Be the escalation point for vendor issues which may impact study timelines, budget or quality
Responsible for the Study Planing. Develop Study Timelines and followup planning execution to reach the study milestones
Ensure overall study quality management and inspection readiness, lead deviation management process

Education and Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years).
5+ years of management responsibility
Proven leadership skills
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

MUST HAVES
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Early Phase Oncology Experience - 1, 1a, 1b, 1/2:

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FDA and EMA Submissions:

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Strong understanding of pharmaceutical product experience and life cycle management

Knowledge, Skills and Abilities:

Comprehensive therapeutic area knowledge, clinical development guidelines and directives and regulatory guidelines
Expert knowledge of the key principles of cross functional project management (Time, Quality, Cost)
Excellent oral and written communication and presentation skills
Demonstrated leadership and interpersonal skills including the ability to lead, motivate and coordinate crossfunctional project teams
Proven flexibility and ability to effectively prioritize workload and resources for project team members in a frequently changing environment
Skilled in process improvement and strategic development, especially as it applies to clinical trials, clinical development and project management
Ability to coach, mentor and lead global and/or crossfunctional teams with a cultural awareness

Our 4i values:

Integrity
Innovation
Intensity
Involvement

Work Environment Requirements:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

PPD FSP:
People Who Deliver | PPD Careers - Read about PPD employee experiences