Clinical Operations Manager Position Responsibilities Study Management
Lead execution of clinical studies in various therapeutics areas, in adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations, and International Conference on Harmonization (ICH) guidelines. Responsible for effective management of budgets, timelines and resources for assigned clinical studies from study-start up through final clinical study report. Study Planning
- Incorporate operational delivery aspects and logistics into the protocol and lead document writing and review for the protocol and amendments
- Lead the RFP and selection process for CROs and other study vendors
- Lead the study team to develop a cross-functional, integrated study plan for study start-up and create initial study budget
- Validate the study implementation plan provided by the CRO from study concept through closure and CSR writing. Ensure the timing of the major study milestones and the associated budget to meet the needs of the overall development plan agreed by the Project Team.
- Review study feasibility assessments provided by the CRO(s)
- Lead site selection and site qualification discussions with study team and CRO
- Responsible for managing the logistics of clinical material in collaboration with both internal and external team members
- Lead training of study team, study sites and vendors assigned to clinical studies
- Participating and presenting at Investigator Meetings, Kick-off meetings, etc.
- Oversee CROs and provide timely input to ensure that the studies are executed according to the agreed project plans
- Complete study risk assessments and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans
- Lead the study team kick-off meetings and subsequent team meetings
- Participate in site evaluation visits and on-site monitoring visits with external study-assigned monitors
- Review of monitoring visit reports and TMF
- Review contracts, work orders and invoices prior to submission to management for approval
- Development of clinical study tools for clinical sites (i.e., patient reminders, phone screen log, advertisement, etc.)
- Medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND etc.
- Oversee end of study close-out, reconciliation and reporting activities
- Track progress of assigned studies and report updates to upper management
- Maintain study related documentation according to SOPs and GCP requirements
- Assist the Sr. Director of Clinical Operations in the design, update and implementation of innovative and best-in-class procedures and SOP's related to clinical study development and execution, in collaboration with Quality Assurance
- Continually identify opportunities to improve study level performance
- Bachelor's or Master`s degree in biological science, nursing, pharmacy as a minimum; Advanced degree strongly preferred
- Minimum 5+ years of experience in the pharmaceutical industry leading global studies with multiple vendors, accountable for adequate manpower, finances, achievement of task-based timelines, product safety and protocol integrity.
- Extensive project and vendor management with demonstrated analytical and problem-solving skills
- Extensive prior experience with conducting Phase I, II and Phase III studies
- Knowledge of ICH/GCP and FDA Regulations
- Knowledge/experience with EDC, eTMF and CTMS systems including Medidata Rave and Inform database software
- Knowledge in MS Office and MS Project
- Track-record of effective communication and issue resolution with external vendors and internal teams
- Strong written/verbal skills
- Highly motivated, thoughtful, independent individual capable of functioning in a fast-paced environment with changing demands and opportunities
- Travel required - approximately 10%
- Medical, Dental, and Vision Insurance
- 401K Plan
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.