Reports To: Clinical Program Lead
Location: Remote or Richmond, VA or Slough, UK
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
Education: 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
Strong problem-solving skills
Excellent communication skills, both written and verbal
Must be fluent in English
Detail oriented and possesses technical expertise (e.g., spreadsheets, metrics, and data flow management
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes
3 weeks’ vacation plus floating holidays
401(k) - Company match of 75% on your first 6% of contributions
U.S. Employee Stock Purchase Plan- 15% Discount
Comprehensive Medical, Dental, Vision, Life and Disability coverage
Health and Dependent Care Flex Spending options
Leverage Concierge/personal assistance services
Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
Gym, fitness facility and cell phone discounts
Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.
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.
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