Clinical Site Operations Manager
- Experience Level
- Experienced (non-manager)
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 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 Site Oversight & Operations Relationship Lead, 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 Site Oversight & Operations Relationship Lead, you are The Site Oversight & Operations Relationship Lead is the main Pfizer point of contact for investigative sites as well as
accountable for safeguarding the quality and patient safety at the investigator site. This role is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies. As part of the oversight responsibilities, this role will utilize and interpret data from analytic tools, in conjunction withcountry and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. This role is also accountable for identifying CRA performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place. The Site Oversight & Operations Relationship Lead is the “face of the company” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and their reputation is that of “Partner of Choice.”
The Site Oversight & Operations Relationship Lead proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and pipeline opportunities. This role is accountable for study start up, activation, and execution to the plan for targeted sites. In addition to being the main point of contact, the
lead will help coordinate with other roles and functions that will interface with target sites, thereby, simplifying site communications and enhancing overall visibility into and confidence of quality of site-level activities.
- 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 and manages the tactical execution of one or more clinical studies from study startup through database release.
- provides quality oversight to the Contract Research Organisation (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 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
- 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.
- core member of the Study Team and will represent the CRO on matters of study execution.
- 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.
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.
- 5+ years of clinical research experience required, including at least 2 years experience in clinical trial management
- Read, write and speak fluent English; fluent in host country language required.
- Solid knowledge of clinical development processes with strong emphasis on monitoring
- Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred)
- Site Management/Monitoring (CRA) experience (preferred)
- Project management experience preferred in the clinical development area
- Ability to lead, troubleshoot and influence for delivery
- Independent approach
- Experience implementing centrally designed and developed initiatives on a local basis
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.
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