Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.
Location/Division Specific Information
This role will be embedded within a client dedicated team. You will work alongside the clients own experienced personnel, as well as PPD colleagues to deliver innovative clinical support.
Job Purpose and Key Responsibilities:
- The primary responsibility of the NIS PM is to support the setup of studies within the Non-Interventional Study (NIS) portfolio, with a focus on database studies, Indirect Treatment Comparison (ITC) studies, meta-analyses, and Randomized Clinical Trial (RCT) analyses, through to the Final Protocol Approved (FPA) or disclosure milestones. Depending on business needs, may also be assigned to more complex studies or remain on a study for a longer duration.
Key Responsibilities include the following:
- Planning and leading the delivery of assigned studies to timelines, quality, budget, company standards and scientific requirements; from concept to a handover point applicable to the study type, which may be up to final study report and archiving.
- Supporting the coordination and delivery of a fully feasible Study Protocol and any other relevant study documentation.
- Supporting the Scientific Lead in the assessment and selection of appropriate vendors and leads on the engagement and management of selected vendors.
- Working with matrix partners, manager and/or NIS TA Study Delivery Head to develop and manage study level budget within project budget allocation.
- Ensuring prompt escalation of study and project level issues and risks to manager or NIS TA Study Delivery Head, as appropriate.
- Working effectively in partnership with the Scientific Lead (and extended team, if required) to deliver assigned studies. Interacts effectively across boundaries with other global functions using influencing and relationship-building skills.
- Ensuring compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for NIS such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and client SOPs, for all products and services delivered for their designated studies.
- May lead or contribute to initiatives to improve processes and/or ways of working.
SPECIALISED KNOWLEDGE: The position requires a performance-driven, study management professional with a strong sense of urgency, exceptional organizational credibility, and a basic understanding of the NIS scientific and operational aspects of the pharmaceutical R&D business. Demonstrated competency in the following areas:
- Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigor and risk.
- Excellent leadership, influencing and negotiation skills.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives.
- Sustaining energy and well-being.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.
- Ability to work independently and proactively and to take on leadership roles on crossfunctional teams.
- Budgeting and forecasting, commercial and financial acumen.
Basic Requirements:
- Bachelor’s degree in life sciences or related discipline.
- 3 or more years of experience in clinical operations or related research.
- In-depth knowledge of study management, essential regulatory guidelines worldwide, and the clinical development process.
- Knowledge and experience of Non-Interventional Studies (NIS).
- Respiratory experience
Preferred Requirements:
- Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience.
- Proven expertise in the proactive identification of issues which may impact clinicalprogrammes coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
- Demonstrated experience leading in a matrix environment to deliver studies, develop clinical plans, and manage change.
- Proven experience in managing relationships with vendors to ensure successful delivery of studies
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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
