Clinical Trial Program Manager (NIH)

Job Description

Are you excited about promoting and ensuring ethics in human subjects' research? Are you ready to lead a growing team of regulatory professionals?

Ripple Effect is looking for a Clinical Trial Program Manager with eight years of experience to support our client’s mission at the National Institute on Deafness and Other Communication Disorders (NIDCD). This role will work closely with NIDCD Program Managers and funded research investigators to advise on, oversee, and develop supporting materials for NIDCD's portfolio of clinical trial research.

If this position sounds interesting, there’s a place for you here at Ripple Effect! We are a diverse, progressive, and engaging work environment. We offer a multitude of incentives and flexible work options that work for you and your lifestyle.

General Information

Job Code: SHR-RA-04M, SHR-RA-05M

Location: Bethesda, MD

Employee Type: Exempt, Full-Time Regular

(Ask our recruiters about flexible work arrangements)

Telework: Full-Time

Manager: Yes

Clearance: Other Clearance

Number of Openings: Multiple

Salary Range: $93,000 - $125,000 per year per year (how we pay and promote)

Responsibilities

Develop tools such as templates, outlines and/or guidance documents to assist performance sites in developing clinical trial implementation documents and SOPs.

Review study-specific materials submitted by research teams, e.g., draft and final clinical protocols, informed consents, protocol amendments, and clarification memos.

Maintain and organize records of protocol versions, FDA and IRB submission dates, and FDA & IRB approval dates.

Develop a tools record and track the status and verify the completion of pre-implementation requirements of each clinical trial.

Develop and implement procedures to ensure the successful closeout the clinical trials and safe transition of subjects off the clinical trials.

Train the study coordinators/delegated study staff to independently and effectively manage the clinical trial documents, activities and sites.

Develop and maintain a timeline to track contractor activities deliverables as well as coordinate and oversee the activities, deliverables, and timeline of other contractor staff.

Collect, organize, and file all tools developed by the contractor in a secure shared file that is easily assessable to client staff.

Ensure industry standard operations and quality management of all clinical trials.

Conduct Site Initiation Visits and train study coordinators/delegated study team staff.

Provide client and the study research team evaluations reports identifying issues and recommended solutions to address issues.

Conduct evaluations, advise, provide solutions to the study research team on clinical data management procedures to ensure reliability and compliance with international and regulatory data standards.

Evaluate and advise the study team on development of a Clinical Data Management Plan.

Provide client and the study research team with evaluations reports identifying issues and recommendations for solutions to address issues.

Develop tools that will be utilized by the clinical trials community to establish and improve clinical trial capacity.

Facilitate virtual meetings as needed.

Performs other job-related duties as assigned.

Requirements

Master's degree in public health or healthcare, biomedical science, or regulatory field.

8 years' experience with clinical research and protocols, with at least 6 years leading or overseeing clinical trials research or reporting.

Basic Requirements

Experience overseeing clinical trial research compliance, quality, and rigor.

Demonstrated strength in verbal and written communication skills, including presentation and training skills.

Ability to work productively in Microsoft Office Suite, including Microsoft SharePoint to accomplish tasks.

Highly organized, efficient, pro-active, and extremely detail-oriented.

To be successful at Ripple Effect, you must be able to pay attention to details, clearly communicate, work independently, and have an eagerness to learn. Learn more about what it takes to become a Rippler here.

Skills That Set You Apart

Experience advising and training staff on clinical research regulatory concerns

Familiarity and experience with NIH clinical trial policies from an oversight perspective

Experience with FDA processes

Clinical patient care experience and experience with clinical trials

Program management training and experience

If you don’t have all of the skills above, don’t be discouraged—no resume paints a complete picture of a person. There’s a good chance you’re more wonderful than you think, so please apply!

About Ripple Effect

Ripple Effect is an award-winning women-owned small business providing provides professional consulting and exceptional talent for federal, private, and non-profit clients. We deliver multi-disciplinary solutions across communications & outreach, research & evaluation, policy & program management, digital transformation, and strategic staffing solutions with a focus on science, research, and healthcare domains.

Hiring Process Life at Ripple COVID Response DEI

Benefits

Ripple Effect rewards our employees for their contributions to our mission in many ways, from competitive pay and exceptional benefits to a range of work/life programs based on your employment classification and personalized preferences.

Ripple Effect is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, political affiliation, or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. If you have a disability or special need that requires accommodation during the hiring process, please let us know by contacting our HR department at or your recruiter. Eligibility for employment will be verified using E-verify.