The Manager of Clinical Operations works with the Clinical Operations department to ensure the successful management, performance, and career development of all Clinical Research Associates. This role provides training and support related to clinical operating activities in the conduct of clinical trial projects, while assuring compliance with Good Clinical Practices (GCPs), ICH, Standard Operating Procedures (SOPs), and policies and procedures established by CRC and its clients.
Essential Duties and ResponsibilitiesClinical Operations Management- Hire, train, mentor, and develop assigned team.
- Anticipate and remediate resourcing issues, oversee workloads.
- Work with Project Managers (PMs) and Clinical Trial Managers (CTMs) to ensure appropriate resources are allocated per study/project.
- Liaise with PMs and CTMs to ensure deliverables/targets are met, ensure project hours are met, ensure excessive total hours are noted and action taken/escalation occurs as necessary.
- Liase with Sponsors and support PMs and CTMs on Sponsor calls regarding selection of assigned team for a program and/or issues with performance during an ongoing program.
- Oversees the performance of direct reports and performs annual reviews, addresses employee relation issues, and escalates issues.
- Review and approve timesheets, expense reports, as needed.
- Conduct regular meetings and maintain one-on-one communications.
- Identify training needs, and evaluate and implement staff training.
- Stay current on developments in the field of clinical research.
- Assist with the development of strategies in assigned areas, as needed.
- Develops improvements initiatives to increase compliance and follows up on non-compliance, if applicable.
- Participates in sponsor audits and regulatory agency inspections.
- Oversees development of departmental SOPs and working instructions.
CRAs Management- Provide clinical management oversight of clinical projects to ensure consistent on time completion of client deliverables.
- Provide clinical expertise to project team as needed.
- Participate in the development of the clinical portion of client proposals including preparation of clinical monitoring budget and text.
- Assist with/in bid defense meetings and with proposal development as needed.
- Assist with the development of clinical monitoring strategies, as needed.
Qualifications- BS/BA degree required or an equivalent education, training and experience.
- Experience in a CRO, or pharmaceutical industry or hospital setting is preferable.
- Minimum of 5 years' experience as Clinical Research Associate.
- Understanding the processes associated with the conduct of clinical trials and document management operations.
- Understanding of clinical research regulatory requirements is required.
- Ability to work independently with minimal supervision.
- Strong computer skills, including Microsoft Word and Excel.
- Ability to adhere to standard operating procedures.
- Meticulous attention to details.
- Demonstrated ability to lead and motivate a team.
- Excellent organizational, communication (verbal and written) and interpersonal skills.
- Ability to work independently and prioritize to proactively address any challenges in order to meet deadlines.
- Strong problem solving, deductive reasoning and decision-making skills.
- Ability to travel
