Clinical Operations Manager III

CAMRIS International • Bethesda, MD

9d • Onsite

About The Position

Overview We are seeking a Clinical Operations Manager III to support the National Institutes of Health’s (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference. CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs. Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad. Responsibilities Manage the oversight of sponsor essential documents/ records files for multi-center studies and electronic trial master files. Advance the writing of documents as part of the quality management system (SOPs, policies, audit reports, etc.), by both actively leading the development of documents and facilitating working groups to collaborate and write documents. Stay current with changes to current industry standards and applicable regulations for quality in clinical research. Conduct quality assurance activities such as internal audits, reviews of regulatory documents, drafting summary reports for division leadership, and others as assigned. Participate in preparations for regulatory inspections, which may include reviewing inspection readiness plans, mock inspections, and risk-based management of program inspection quality events. Assist in resolving compliance issues at clinical sites, clinical vendors, and contracted research facilities; and provide assessment of the impact of any deficiencies. Provide guidance to other groups in DMID that are funding, overseeing, and implementing clinical research to understand how clinical research is supported by DMID. Based on understanding of Division operations, look for ways to standardize processes to improve quality and/or facilitate efficiency. Performs other duties as assigned.

Requirements

• Bachelor’s degree in a related discipline.
• Minimum of three (3) years of experience in clinical research or a related field.
• Thorough knowledge of clinical trial documentation including Essential Documents/Records according to ICH.
• Must be detail-oriented with strong organizational skills.
• Experience with US and international Good Clinical Practice (GCP), guidance documents, and industry best practice in all areas of a GxP environment.
• Extensive experience with electronic trial master file systems and electronic data capture.
• Excellent communication skills both verbally and written; and across functions internally and externally.
• Ability to organize, prioritize and deliver tasks & projects according to pre-defined deliverables.
• Ability to effectively build and maintain relationships with multiple departments and external entities (e.g., Investigator sites, clinical Vendors/CROs) in order to effectively solve problems.
• Excellent multi-tasking, analytical, organizational and teamwork skills.
• Ability to troubleshoot, identify root causes, and systematically resolve problems.
• Ability to produce high-quality work on complex problems with cross-functional involvement.
• Proficient in Window based software to include Excel, Word.

Nice To Haves

• Experience in regulatory inspections from the US FDA or similar government regulatory authorities is preferred.
• Experience conducting or overseeing audits is preferred.
• Experience working at a clinical research site or overseeing multicenter clinical research is preferred.
• Experience in the NIH or other government agency is preferred.

Responsibilities

• Manage the oversight of sponsor essential documents/ records files for multi-center studies and electronic trial master files.
• Advance the writing of documents as part of the quality management system (SOPs, policies, audit reports, etc.), by both actively leading the development of documents and facilitating working groups to collaborate and write documents.
• Stay current with changes to current industry standards and applicable regulations for quality in clinical research.
• Conduct quality assurance activities such as internal audits, reviews of regulatory documents, drafting summary reports for division leadership, and others as assigned.
• Participate in preparations for regulatory inspections, which may include reviewing inspection readiness plans, mock inspections, and risk-based management of program inspection quality events.
• Assist in resolving compliance issues at clinical sites, clinical vendors, and contracted research facilities; and provide assessment of the impact of any deficiencies.
• Provide guidance to other groups in DMID that are funding, overseeing, and implementing clinical research to understand how clinical research is supported by DMID.
• Based on understanding of Division operations, look for ways to standardize processes to improve quality and/or facilitate efficiency.
• Performs other duties as assigned.

Benefits

• CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 251-500 employees