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.
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.
A day in the Life:
- 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:
Education:
- 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
Experience
- Demonstrated study management / leadership experience
- Demonstrated oversight of CROs
- Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend
Knowledge, Skills, Abilities
- 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)
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.
