Job Code: USCD01
Position: Director, Clinical Operations
Department: Clinical Development – Clinical Operation
Reports to: Executive Director, Clinical Operation
Location: Remote, USA
The (Associate) Director, Clinical Operations is a key position responsible for the global execution of clinical studies and programs. The position will report to the Executive Director, Clinical Operations. The (Associate) Director, Clinical Operations must have a mastery of FDA regulations, GCP and ICH guidelines relating to industry sponsored clinical research. The (Associate) Director will lead a cross functional internal team and engage and manage vendors/partners. Establish working practices that promote and maintain a culture of quality, compliance, and inspection readiness at all times. Lead operations activities of project(s) and/or program(s) and provide oversight.
- Establish goals in implementation of current company program objectives based upon principles of good clinical practice (GCP) in clinical operations and project management.
- Accountable to ensure study teams are fully resourced with appropriately skilled staff and that clinical programs are implemented, and risks are managed within scope, on time and within budget.
- Accountable for the delivery of assigned clinical program milestones.
- Management of third-party relationships engaged in the clinical programs.
- Work with functions outside the clinical group to ensure task completion, promote understanding and awareness of clinical programs.
- Actively manage and complete tasks, documents, plans, etc. (draft and review) to ensure successful completion of assigned projects with focus being clinical operations and clinical project management components, but also includes functional input to documents/decisions, etc. lead by other team functions.
- Develop and may manage clinical operations staff to meet current and future business needs.
- Lead clinical operations activities in the preparation and coordination of clinical trial set-up, maintenance, and closure in accordance with GCP and SOPs.
- Provide study management by interfacing with representatives from key functional groups such as: Clinical Development, Data Management, Biostatistics, Regulatory Affairs, QA, Medical Writing, CMC, and Research
- Actively support other functional groups with clinical trial set-up, maintenance, and closure (e.g., data management, biostatistics, medical writing, clinical trial material vendors, etc.)
- Provide expertise and direction on the activities involved with planning, conducting, and reporting of clinical data.
- Lead trial initiation activities including protocol development, activities for investigator site selection and regulatory preparedness, investigator budget and contract negotiation, and clinical vendor procurement activities.
- Actively engage in study oversight to monitor adherence to GCP with timely and appropriate escalation of issues, as necessary.
- Participate in the development and review of regulatory documents as appropriate.
- Conduct site clinical site monitoring activities as needed.
- Meet with and gather information on new vendors to build a knowledge base and maintain understanding of available services.
- Complete vendor proposal requests in conjunction with the contracts and outsourcing team as required and actively participate in the review and selection process of clinical vendors.
- Ensure adherence to business processes with respect to vendor contracts and invoicing procedures.
- Serve as key liaison with project and site management clinical research organizations (CROs) and monitor and track adherence to contracts and budgets.
- Participate in trial budget reviews and invoice reconciliation.
- Quality and Process Improvement:
- Participate in development and review of clinical SOPs.
- Maintain 100% compliance with SOP training.
- Conduct audits and inspection readiness visits to investigator sites and vendors.
- Work closely with management and functional areas outside of clinical to influence processes and program decisions while driving business process improvement initiatives.
- Bachelor’s degree. Biological Science or related field, preferred.
- At least 7 years of work experience in the pharmaceutical and/or drug development industry.
- Experience with management of clinical research organizations or drug development partnership relationships.
- Thorough understanding of and experience with the drug development process through multiple study phases (e.g., Phases I through IV).
- Registration and regulatory response experience.\
- Previous management experience in leading a team of people to deliver an objective.
- Practical experience in initiating, maintaining, and terminating clinical trials in the role of clinical operations/development within industry.
- Practical experience performing project management for a cross-functional project.
- Experience managing remote employees, may be matrix management experience.
- Experience with development of prospective site-selection criteria, site documents and study set-up.
- Practical experience in initiating, maintaining, and terminating clinical trials.
- Experience with management of CROs or other vendor relationships.
- Experience with reviewing adequacy of site/clinical-proposed documents for compliance with relevant regulations
- Protocol development experience
- Ability to deal with time demands, incomplete information or unexpected events.
Skills and Attributes:
- Attention to detail.
- Excellent time management and organizational skills.
- Proven ability to manage multiple tasks and associated deadlines.
- Exceptional communication and interpersonal skills
- Strong computer literacy, including Microsoft Office suite
- Strong project management tools/process experience (e.g., management integration, scope, timeline, cost quality, resources, communications, risks, and procurement)
- Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment Extensive experience in successfully managing the operations of domestic and international clinical trials.
- Understanding of the requirements and company/regulatory needs concerning project documentation.
- Demonstrated success in the conduct of multinational clinical trials and management of multiple service providers.
- Skills and experience with budget development, negotiation, forecasting, and finance.
- Line-management skills, resource management skills, ability to speak in public and training of both in-house and partner personnel is essential.
- Significant (domestic and international) travel may be required.