Senior Study Manager
Home Based – Vaccines
Job Locations: (All) | US-Remote
Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we’re hoping you’re here for the latter.
Who are we?
We Are PRA.
We are 16,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
Who are you?
You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Senior Study Manager, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Still here? Good. Because if this is you, we’d really like to meet you.
What will you be doing?
As a Senior Study Manager, you are responsible for 1 or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies
The Study Manager leads and manages the tactical execution of one or more clinical studies from study startup through database release.
The Study Manager provides quality oversight to the Contract Research Organisation (CRO) and of the CRO deliverables related to study execution. The Study Manager leads and coordinates the execution of a clinical trial from Study start-up through Database release 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 The Study Manager 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. The Study Manager is a core member of the Study Team and will represent the CRO on matters of study execution.
The Study Manager works with functional lines and directly with CRO line functions to resolve or triage site level issues. The Study Manager will drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy.
For studies where more than 1 Study Manager is assigned may be required to act as lead’ study manager . and will coordinate activities of the other Study Managers assigned.
ResponsibleforStudy Management and oversight of all Study Management functions internally and at the CROs
- Operational Study Management for 1 or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies
- Accountable for the development of realistic detailed study startup and monitoring plans
- 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
- Coordinates study/protocol training & investigator meetings
- Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
- Accountable for the delivery of the study against approved plans
- 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.)
Study Management Oversight
- Approves the Study Startup, Study Monitoring & protocol recruitment plans
- Approves & oversees drug supply management manages flow of drug supply to the sites & set up Interactive Voice Randomisation System with Supply Chain Lead
- Reviews consolidated Pre-trial assessment reports, feasibility outputs, etc.
- May support study level submission readiness
Study Team Interface
- Leads and oversees all elements of study startup and monitoring functions both internally and at the CROs to ensure delivery & compliance with all applicable Standard Operating Procedures (SOPs) and Quality Standards, interfacing directly with CRO to determine Feasibility / Study Startup, Monitoring / Management & Site Contracting Groups
- Works proactively with CRO and data management functions to ensure alignment on data flow and timely delivery
- Shares and escalates plan deviations to Clinical Project Manager (and study team)
- Provides ongoing assessment of subject enrollment / discontinuations to inform accurate forecasting for financial planning
- Provides operational input into protocol design
Subject Matter Expertise
- The Study Manager will be the technical expert for study management systems and processes
- The Study Manager will champion the implementation and use of harmonized, consistent processes and excellence in Study Management deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals.
- The Study Manager will be responsible for the technical oversight of the CRO to include but is not limited to: mentoring, standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics.
- The Study Manager partners with CRO Managers to proactively identify and resolve study operations staff performance issues.
- For project-specific audits and inspections, the Study Manager can serve as a resource
What do you need to have?
- BS/Nurse minimum of 5 years relevant experience OR
- MS/PhD minimum of 3 years relevant experience
Training and Education Preferred:
- Extensive global clinical trial/study management experience
- Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
Prior Experience Preferred:
- 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.
- Minimum 5 years experience in clinical research, including a minimum 2 years full service project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
- Reads, writes and speaks fluent English; fluent in language of host country.
- A graduate degree or undergraduate degree.
- An undergraduate degree with 7 years of experience in clinical research and at least 3 years as a full service project manager.
- Or a Graduate degree with 5 years of experience in clinical research and at least 2 year as a functional team lead role or single service project management.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.