Manager, Clinical Operations - United States
- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Company’s Development Sciences group is responsible for everything from research and discovery to post-market clinical development.
- Development Sciences involves all bench and clinical research and the associated groups that support those endeavors.
- Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.
- Come join our team and make a meaningful impact on patients’ lives.
- The Clinical Operations Manager takes on a leadership role in clinical operations study teams to ensure the highest quality of clinical operations deliverables.
- The Clinical Operations Manager holds the role of CLO Study Lead. In this role, s/he leads all day-to-day Clinical Operations functional activities associated with the execution of clinical trials. The Manager is responsible for oversight of the CLO study team, the Clinical Research Organizations (CROs), and third party vendors associated with the study. S/he is capable of overseeing and executing on all delegated tasks associated with clinical trial execution.
- A Manager may also have the opportunity to take on a Regional Study Lead role on highly complex global multi-country studies.
- Study Planning & Management:
- Ensure timely and quality execution of study according to the protocol, study execution plan, and GCP guidelines (including company SOPs, ICH and FDA and other Health Authorities (HAs))
- Oversee study feasibility assessment activities (if applicable)
- 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
Team timeline and budget:
- Lead cross-functional effort to define enrollment strategy and plan for the study
- Participate in strategic study planning meetings (such as DMC, advisory board, steering committee)
- Provide study status updates to the Study Team and Study Team Lead
- In collaboration with appropriate teams, oversee and approve vendor evaluation and selection
- 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
Study Conduct Startup:
- 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
Enrollment and Maintenance:
- Ensure adherence to study enrollment strategy and plan
- Ensure adherence to monitoring plan
- Ensure adherence to monitoring oversight SOP
- Ensure timely site payments
- 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
- At the Manager level, you may have up to 2 direct reports; actual number of direct reports vary depending on business needs
EDUCATION AND EXPERIENCE:
- BA/BS or higher in nursing, life or health sciences is preferred.
- 6 + years of clinical research experience
- 4 + years of experience in pharmaceutical /biotech industry experience (preferrably in study lead capacity)
- Some line management experience (2+ years) is preferred