Clinical Operations Lead (Pain Therapeutic Area)

Key Accountabilities

• Provide leadership, local/global strategic planning and operational delivery of assigned clinical studies/program through all phases of study management (study start-up, conduct/maintenance, closure), in accordance with Everest quality standards, all applicable regulations, timelines and budget commitments.
• Ensure the effective identification, initiation and motivation (patient recruitment/retention) of clinical study sites.
• Focus on internal and external customers service (Sponsors, study sites, vendors) related to site management and clinical monitoring activities to ensure timely and high quality deliverables through CTMS/eTMF and/or tracking tools.
• Provide oversight and quality control review for set-up and maintenance of studies in Clinical Trial Management System (CTMS) and Trial Master File (TMF).
• Plan and conduct initial and ongoing training for the study team on project-specific matters and enlist therapeutic assistance where applicable.
• Drive the successful activation of trial sites according to time, quality/scope and budget parameters.
• Serve as initial point of contact for all clinical management and monitoring issues, vendors and other functional areas, escalating as required.
• Develop a monitoring plan as well as monitoring tools.
• Oversee the preparation, conduct and timely completion of all monitoring visit reports, reviews them for appropriate content, and ensures effective follow up and resolution of site issues. May conduct monitoring visits as necessary.
• Collaborate with other functional departments to identify issues and risks to clinical activities; assists in the development of mitigation plans to minimize risk.
• Aid the functional clinical operations delivery team.
• Aid with the preparation and negotiation of sites contracts/budgets and prepare payments for vendors/study sites.
• Aid with the preparation and submission of regulatory documents to responsible regulatory agencies, authorities, IRBs and/or Research Ethics Committees.
• Develop and/or review information provided to study subjects, i.e., informed consent forms.
• Maintain the quality of clinical deliverables and address quality issues with the appropriate team member.
• Perform COL II responsibilities as needed.

Qualifications and Experience

• Bachelor’s degree or RN in a life science or related field of study.
• Ten (10) years’ clinical research trial and/or monitoring experience.
• Thorough knowledge of ICH-GCP guidelines and applicable regulations.
• Demonstrated experience conducting clinical trials within the Pain therapeutic area (acute and chronic).

Benefits & Compensation

• We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a 401(k) retirement / pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.