Study Start Up Project Manager
Study Start Up Project Manager – Remote Based (US)
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 17,000+ 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 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 Start Up Project 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?
The Start Up Project Manager is responsible for defining, developing and delivery of the Global Study Start Up Project Plan by partnering with Study Manager, Clinical Trial Application Group, Clinical Research Site Assistants, CRO Study Start Up and Site Operations Relationship Lead and others as required for Phase 3 and other supported studies.
- Partner with Study Optimization to leverage site intelligence to inform the Start Up Project Plan.
- Partner with the Targeted Site Investigator Network Strategy Implementation Lead to ensure accelerated start up strategies are leveraged at Targeted sites.
- Partner with Clinical Trial Application and CRO Start Up functions to align all country and site activities to Start Up Project Plan
- Identify risks to site activation and develop mitigation plans. This role is also accountable for resolution of Site Activation escalations for Study Teams including offering options for mitigation (both at the study and site level).Leader of the Start Up Sub team and a core member of the Study Management Operations Sub team.
- Ad-hoc member of the Core Team Meeting throughout study start up.
- Accountable for startup of sites to be Ready to Enroll.
- Leader of the Site Activation Sub team and a core member of the Study Management Operations Sub team
- Lead the cross functional site activation team internal plus CRO, utilizing the appropriate team members to support implementation of the Start Up Project plan.
- Ensure accelerated start-up for Targeted Sites leveraging the Site Relationship Partners and Site Activation Partners.
- Drive delivery of all Targeted and CRO supported sites that are Ready to Enroll to the Start Up Project plan.Resolve escalated issues identified by the site activation subteam in partnership with the Study Manager through the Study Management Operations Subteam with the CRO.
- Oversee and drive execution of study start-up activity at CRO.
- Ensure alignment to the DVSO scenario planning.
- Accountable for defining, developing and delivery of the Global Study Start Up Project Plan, including:
- Track and communicate with Study Management Operations Subteam & Core Team. Drive alignment of CRO study start up plan to country and site level.
- Agree to deliverables on a site-level basis with the CRO and monitor adherence to these. Promptly recognize and remediate potential delays, and escalate non-performance as needed.
- Use site activation reporting tool following site ID, up to and including, site Ready to Enroll, incorporating input from DCSM regulatory submission/approval timelines in order to achieve agreed upon milestones in DVSO.
- Implement strategies within Study Start Up Subteam on assigned study to ensure consistent and efficient communications internally and with the CRO.
- For PFE Targeted sites, drive the Site Relationship Partner to manage site activation timelines across targeted sites to the level of the individual site:
- Understanding critical path activities at the site level
- Ensure planning for individual components of IIP documentation (including site contracts and budgets and ICD) in partnership with CRO Start Up and/or Clinical Research Site Assistants.
- Ensure site readiness activities are considered in the overall timelines for each site to ensure ready to enroll
- Supplies on site (IP and non-clinical supplies)
- Systems access
- Training (break blind, systems training, etc.)
- Leverage all available intelligence to inform the Study Start Up Strategy:
- Partner with Site Intelligence to ensure clear communication of data.
- Obtain CRO, CTA, Country and Targeted Site level input to plans.
- Identify risks to site activation and develop mitigation plans, including providing input to SciOps materials:
- Identify and capture key risks to site activation for inclusion in SciOps presentations.
- Develop site activation mitigation plans and monitor effectiveness through Study Start Up Subteam.
- Identify improvements and efficiencies to site activation processes and share lessons learned broadly with key stakeholders
What do you need to have?
- Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution; a licensed health-care professional, i.e., registered nurse
- 8 years of relevant experience
- Minimum 5 years of experience in clinical research, including a minimum of 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.
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