Senior Study Manager
- Experience Level
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.
As a Senior Study Manager you will be responsible for providing quality oversight to the Contract Research Organisation and of the CRO deliverables related to study execution. You will lead and coordinate the execution of a clinical trial from study start-up through to database release and inspection readiness to ensure the timely delivery of quality study data, providing input to and supporting the compilation of sections to clinical study reports and 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.
- 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
- 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 LeadReviews consolidated Pre-trial assessment reports, feasibility outputs, etc.
- Act as 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.
Innovative, forward-thinking and delivery-focused.
Here at PRA we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
- A Batchelors Degree, or equivalent required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing or Pharmacy).
- Extensive experience of clinical trial management in the pharmaceutical industry or CRO.
- Clinical Operations knowledge, extensive project management experience and strong communication skills are required.
- Effective study team leadership skills and proven ability to foster team productivity and cohesiveness.
- Flexibility to manage global or regional study teams in a virtual environment.
- Excellent decision making skills and strong financial management skills are essential for this position.
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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