Location: Remote or Richmond, VA
Our Client is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. They are dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Their logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. The company has a strong pipeline of products and candidates designed to both expand on its heritage in global opioid use disorder treatment and address other substance use disorders as well as mental health co-morbidities such as schizophrenia.
The Study Manager has responsibility for all study management aspects of assigned studies within agreed upon budget, timelines, and internal and external requirements, from study start up to study close out/reporting/filing.
The responsibilities of this job include, but are not limited to, the following:
- Leads and coordinates the execution of one or more clinical studies from study start-up through data reporting (Tables, Listings and Figures, and CSR) and inspection readiness to ensure timely delivery of quality study data within agreed upon budget and timelines
- Lead the development of the protocol; Ensure that all aspects of clinical research protocols are properly planned and executed according to regulatory requirements (e.g. ICH, GCP) and provide recommendations regarding the operational feasibility of selected study designs
- Provides leadership to the teams in the setting of realistic recruitment targets and delivery milestones
- Forecast and manage the Clinical Trial Budget for the program. Ensure compliance with approved budgets in coordination with Global Program Lead and Portfolio management function.
- Identify sourcing strategy for the study and lead Clinical Research Organizations (CRO) selection.
- Oversees CRO and timeliness/quality of CRO deliverables according to protocol requirements, study plans, health authority regulations, internal Policies/SOPs and ICH/GCP guidelines
- Oversees CRO Clinical Monitoring function to include review of Monitoring Plans, generation of Oversight Monitoring Plans, Annotated Trip Report and Trip report review.
- Single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans. Approve the Study Startup, Study Monitoring and protocol recruitment plans.
- Oversee drug supply management, flow of drug supply to the sites and spot check of drug accountability at both study and site level.
- Oversee recruitment of clinical sites
- Lead study kick-off/study meetings, and work proactively and other study team functions to ensure studies are executed according to plan
- Evaluate study progress reports and results for overall compliance and recommends corrective action, including study termination for non-performance.
- May also input to and support compilation of sections to Clinical Study Reports
- Drives decision making and works closely with the Clinical Program Lead (CPM) to provide input to operational strategy
- BS, MS, PhD in relevant scientific/biomedical field or Associate level RN
- Minimum 5 Years of clinical research related experience, e.g., as a Clinical Development (or Clinical Trials) manager, preferably in the field of CNS, psychiatry/psychology, or addiction.
- Extensive global clinical trial/study management experience
- Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
- Demonstrated study/project management & leading teams in a matrix environment
- Demonstrated oversight of CROs; understands how to work with vendors to accomplish tasks
- Demonstrated experience in managing per subject costs, vendor, ancillary, and monitoring costs projections and spend
- Ability to interpret study level data, translate and identify risks
- Ability to proactively identify and mitigate risks around site level in study execution
- Understands feasibility of protocol implementation
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
- Clinical Study Reports
- Clinical Research
- Pre Clinical Development
- Clinical Trials
- Good Clinical Practices (Gcp)