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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 are getting life saving drugs into the hands of those who need them the most.
Who are you?
You are a leader that isn't afraid to delegate, but also isn't afraid to get your hands dirty. You look for new and innovative ways to problem solve. You are the ultimate planner and coordinator and are an excellent communicator. You have a serious passion for clinical development. You never settle for what is, but are always pushing clinical development forward to what it could be. You motivate others to do the same. 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.
The Clinical Research Manager be the main point of contact for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
What you will be doing:
- Main POC for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
- Project management of assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
- Accountable for performance of assigned protocols in country in compliance with ICH/GCP, country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visit Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management
- Performs Quality Control visits as required
- Leads local study teams in high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert & coordinates activities across different local country roles.
- Creates and executes local risk management plans
- Supports compliance with CTMS, eTMF and other systems
- Escalates issues to TA Director/CRD/CQM/CTT
- Collaborates with functional outsourcing vendors, investigators and other external partners in studies
- Country POC for programmatically outsourced trials for assigned protocols
- Serves local business needs in his/her country (if delegated, signs contracts and manages budgets)
- Collaborates internally with HQ functions and locall with PV, Regulatory and GMA to align on key decisions
- Builds business relationships and represents the client with investigators
- Shares protocol-specific information and best practices across countries/clusters
Qualifications:What you need to have
- Bachelor's degree in science or similar required. Masters, PhD, MD preferred.
- 5-6 yrs. experience in clinical research required
- CRA experience required
- Oncology experience highly preferred
- Ability to travel up to 30%
- Project/Site Management knowledge
- Demonstrated success of strong organizational skills
- Strong understanding of local regulatory environment
- Strong scientific and clinical research knowledge
- Strong understanding of clinical trial planning, management and metrics
- Ability to focus on multiple deliverables and protocols simultaneously
- 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.