Clinical Operations Lead (Pain Therapeutic Area)

Everest Clinical Research

5d•Remote

About The Position

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest. To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as Clinical Operations Lead (Pain Therapeutic Area) for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. The Clinical Operations Lead will serve as the clinical functional lead, accountable for the site management/clinical monitoring delivery of assigned tasks and project(s) as per scope. The position will provide leadership, mentoring, and technical support to the Clinical Operations team to ensure quality deliverables and achievement of milestones and financial goals. The Clinical Operations Lead is responsible for tracking study progress and assessing compliance of the conduct of clinical trials with regulatory requirements, the clinical study protocol, study-specific plans, and Standard Operating Procedures.

Requirements

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.
Experience working on clinical trials in the pain space (acute or chronic).
Works in an environment that is constantly evolving with new processes and systems. Flexible and resilient with ability to evolve in changing and challenging environment.
Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team, and organizational objectives.
Thorough comprehension of medical terminology and project financial principles.
Moderate travel may be required, approximately 25%.
Must maintain a valid driver’s license and be able to drive to monitor sites.

Responsibilities

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 enlists 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.
Assist functional clinical operations delivery team.
Assist with the preparation and negotiation of sites contracts/budgets and prepare payments for vendors/study sites.
Assist with 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.
Monitoring the quality of clinical deliverables and addresses quality issues with the appropriate team member.
Perform COL II responsibilities as needed.