Sr Project Mgr - Peri Post Approval (Non-Interventional Studies)

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our Project Delivery colleagues within our PPD® clinical research services direct, coordinate and manage the technical and operational aspects of projects, securing the successful completion of clinical trials. This includes collaborating with functional area leads to identify and evaluate fundamental issues on the project and to ensure that solutions are implemented. Project Delivery is vital to helping our customers deliver life-changing therapies.

We have a vacancy for a Senior Project Manager in our Peri Post Approval (Late Phase) Non-Interventional Team in the EMEA region.

Our Non-Interventional Peri and Post Approval Research Operations group consists of colleagues with institutional knowledge, broad and in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

Discover Impactful Work:

Serves as the Project Lead and primary sponsor contact. Accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. Establishes and communicates customer expectations to the project team. Ensures that escalation pathways are adhered to internally and externally. Leads the cross functional project team to meet or exceed deliverables.

A day in the Life:

• Serves as the primary contact between the sponsor and the organization at the project level.

• Ensures escalation pathways adhered to internally and externally (Rules of Engagement – communication pathways).

• On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery).

• Accountable for the overall delivery of the cross-functional project (time, cost, quality).

• Ensures financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, drive the Con Mod process/negotiations and team execution to timelines.

• Establishes, communicates and manages customer expectations to achieve optimal delivery during the project

• Drives Risk Identification and Issue Resolution at project level (RBQM/RESOLVE).

• Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.

Keys to Success:

Education

• Bachelors degree or equivalent and relevant formal academic / vocational qualification

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’).

• Experience in late phase Non-Interventional studies

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.

Knowledge, Skills, Abilities

• Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity)

• Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment

• Effective oral and written communication and presentation skills

• Proactive, solutions oriented and adaptable to changing priorities and situations

• Advanced therapeutic area knowledge and clinical development guidelines and directives

• Strong understanding of the key principles of project management (time, quality, cost), including solid financial acumen

• Sound interpersonal and customer service skills, including the ability to lead, motivate and coordinate cross-functional project teams

• Good judgment and decision making skills and capable of applying critical and analytical strategic thinking skills to manage complex/ambiguous situations

• Ability to negotiate, persuade and influence others, including a cross cultural awareness

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com