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Associate Project Manager - NIS Experience - FSP
Lensa
United States
On-site
USD 70,000 - 90,000
Full time
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Job summary
A leading company is seeking an Associate Project Manager for a role within clinical trials at Thermo Fisher Scientific. This position involves managing global studies, ensuring quality oversight, and leading execution efforts to drive successful outcomes in clinical research. Candidates should have significant experience in clinical trial management, with a focus on leadership, communication, and problem-solving skills, to ensure timely delivery and quality data.
Qualifications
- Minimum 3 years of proven experience with an MS/PhD.
- Minimum 5 years of proven experience with a BS/Nursing.
Responsibilities
- Accountable for study management aspects from start-up to closure.
- Provides quality oversight and drives project execution.
- Leads the team in setting recruitment targets and milestones.
Skills
Education
Job description
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Lensa is the leading career site for job seekers at every stage of their career. Our client, Thermo Fisher Scientific, is seeking professionals. Apply via Lensa today!
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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.
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.
Discover Impactful Work
- The Study Manager has global responsibility for one or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies
- Provides quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study execution.
- Leads and coordinates the execution of a clinical trial from Study start-up through Database close and inspection readiness to ensure timely delivery of quality study data. Study Managers may also input to and support compilation of sections to Clinical Study Reports.
- Will provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans.
- Works with functional lines and directly with CRO line functions to resolve or triage site level issues.
- Will drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy.
- For studies where more than one Study Manager is assigned, may be required to act as ‘lead’ study manager, and will coordinate activities of the other Study Managers assigned.
- Accountable for the development of realistic detailed study startup and monitoring plans as well as study delivery
- Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans
- Leads study risk planning process in context of site and subject
- Coordinate study/protocol training & investigator meetings
- Develops and provides key inputs to Clinical Trial Budget
- Leads inspection readiness activities related to study management and site readiness
- May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
- May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.)
Keys to Success:
- MS/PhD – minimum of 3 years of proven experience
- BS/Nurse – minimum of 5 years of proven experience
- Extensive global clinical trial/study management experience
- Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
- Demonstrated study management / leadership experience
- Demonstrated oversight of CROs
- Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend
- Understands how to work with vendors to accomplish tasks
- Ability to interpret study level data & translate and identify risks
- Ability to proactively identify & mitigate risks around site level in study execution
- Understands feasibility of protocol implementation
- Country level cultural awareness and strong interpersonal skills
- Keen problem-solving skills
- Excellent communication skills, both written and verbal. Must be fluent in English.
- Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management)
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.
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.
- Seniority levelMid-Senior level
- Employment typeFull-time
- Job functionProject Management and Information Technology
- IndustriesIT Services and IT Consulting
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