Project Manager - Clinical Trials Program (Nidcd)

Overview

We are seeking a Project Manager to potentially support the upcoming National Institutes on Deafness and Other Communication Disorders (NIDCD) Clinical Trials Program (CTP). NIDCD needs coordinating and operational services by specialized individuals who have knowledge and expertise in industry standard clinical trial protocol development, readiness for implementation, project management, operations, monitoring, quality management, and data management. This high-profile position is a great career move for candidates looking for a new challenge or to make a difference in the lives of the people that we support. This position forms an integral part of our organization's proposal response, with candidates being proposed as one of the faces for a new CAMRIS International project. We encourage qualified candidates looking to support a new project to apply below.

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: monitoring and evaluation, clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.

Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

This position is a contingent position that is subject to a federal contract award.

Responsibilities

• Manage all clinical trial development initiatives.

• Serve as the primary point of contact for NIDCD staff.

• Prepare and manage budgets for all clinical trials and related projects.

• Assist with preparing the Knowledge Management Plan (KMP) for NIDCD.

• Work closely with the Contracting Officer's Representative (COR) to monitor, verify, and reconcile expenditure of budgeted funds supporting all clinical trials and other projects.

• Develop and/or provide support for Project Plans, including but not limited to plans for space, supplies and budget management for the execution of protocols.

• Review and monitor project scope, timelines and deliverables from project initiation to close out. Schedule monthly project team meetings.

• Compose submission memos and work with Principal Investigators (PIs) to compile documents for protocol submission to the Institutional Review Board (IRB) and other review boards.

Qualifications

• Bachelor of Science Required, Advanced Degree preferred not required.

• Minimum 10 years of experience with clinical trial management of medical devices or clinical diagnostics required.

• Clinical research certification (such as CCRA, CCRC) is highly desired.

• Strong experience in evidence planning, clinical strategy, study design/execution and study monitoring.

• Ability to work across a dynamic organization and influence internal and external stakeholders.

• Ability to resolve compliance or technical issues that may arise during clinical trials.

CAMRIS International offers competitive salaries and comprehensive benefits. Please submit your resume online at www.camris.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

Employment is contingent upon successful completion of a background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.