Clinical Operations, Manager
|Job Title:||Clinical Operations, Manager|
|Location:||San Francisco, California|
|Contact Name:||Pavlina Bullaj|
|Job Published:||June 28, 2017 23:28|
Clinical Operation Manager
SciPro Global are currently looking for a Clinical Operations Manager. We are working with one of our key clients - A company committed to discovering, developing, and commercializing a list of innovative biopharmaceuticals for rare diseases.
As the Clinical Operations Manager, you will take on a leadership role in clinical operations study teams to ensure the highest quality of clinical operations deliverables. As part of the role, you will lead all day-to-day Clinical Operations functional activities associated with the execution of clinical trials.
Working as the Clinical Operations Manager you will be responsible for oversight of the CLO study team, the Clinical Research Organizations (CROs), and third party vendors associated with the study. This role may also give you the have the opportunity to take on a Regional Study Lead role on highly complex global multi-country studies.
Role & Responsibilities
- Ensure timely and quality execution of study according to the protocol, study execution plan, and GCP guidelines (including SOPs, ICH and FDA and other Health Authorities (HAs))
- Ensure timely development and finalization of key study plans and manuals as per the Study Team charter
- Contribute to the development and review of critical study documents, such as study protocol, eCRF, ICF, and others
- Identify CLO risks and mitigations and align with cross-functional Study Team on overall Risk Mitigation Plan
- Identify, resolve or, if necessary, escalate CLO issues that have a significant impact to overall study timelines, other functions, budget or quality to Study Team Lead as per Study Team charter
- Provide CLO study activity timeline and budget inputs to overall Study
- Lead cross-functional effort to define enrollment strategy and plan for the study
- Oversee day-to-day management of CRO and vendors' contracted activities as per oversight plans
- Work with Clinical Outsourcing and Analytics (COA) group to ensure final payments to vendors at study closure
- Lead site identification, qualification, selection and activation activities for the study, including activities such as site and staff training, site budgets, site ICF and coordination of site investigator contracts with Clinical Contract & Grants
- Plan and deliver IM in collaboration with other key stakeholders
- Partner with Patient Advocacy to manage patient travel, housing and associated management of patient costs
- Oversee all study closure activities (sites, reconciliation activities, filing & archiving, and e/TMF related activities)
- Coordinate and oversee data listing reviews
- Ensure timely delivery of clinical documents for the CSR and appendices
- Act as main contact for all CLO study activities and represent CLO on Study Team and associated sub-teams
- Ensure CLO responsibilities for any cross-functional deliverables are met throughout the study, including study close-out and delivery of CLO related appendices for finalization of CSR
- Oversee, train and mentor junior study team CRAs and CTAs on study
- Prepare and communicate study dashboards of standard metrics (KPIs, SQMs) to routinely monitor team activities and ensure compliance to timelines, quality and budget
- Manage protocol deviation reviews in collaboration with CLS
- Provide forecast for clinical supply, including ancillary supplies and comparator drugs
- Contribute expertise to departmental and cross-functional process improvement activities
- Oversee TMF maintenance
Education & Experience
BA/BS or higher in nursing, life or health sciences is preferred.
Min of 6 years of clinical research experience
Min of 4 years of experience in pharmaceutical /biotech industry experience (preferably in study lead capacity)
If you think this is something you would be interested in, please apply directly or alternately send your resume to email@example.com with your contact details.
I look forward to speaking with you!
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