Clinical Trials Portfolio Manager

The Alaka`ina Foundation Family of Companies (FOCs) is looking for a Clinical Trials Portfolio Manager to support our government customer located in Silver Spring, Maryland.

DESCRIPTION OF RESPONSIBILITIES:

Managing all clinical trial development initiatives.

Serving as the primary point of contact for CTC staff. Prepare and manage budgets for all clinical trials and related projects.

Assisting with preparing the Knowledge Management Plan (KMP) for the CTC.

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

Working closely with the Business Management Office (BMO) to initiate and track assistance agreements for the CTC (e.g., Cooperative Research and Development Agreements (CRADAs), Material Transfer Agreements (MTAs), Institutional Biosafety Committees (IBCs), applications, and Clinical Trial Agreements (CTAs)), ensuring full compliance of contract requirements, schedules, and provisions.

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

Reviewing and monitoring project scope, timelines and deliverables from project initiation to close out.

Scheduling monthly project team meetings.

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

Other duties as assigned by Supervisor.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

Must have a High School Diploma and four plus (4+) years of experience in management of projects or programs

Associate's degree is preferred.

REQUIRED SKILLS AND EXPERIENCE:

Must possess prior experience in clinical trials/research.

DESIRED SKILLS AND EXPERIENCE:

Federal and/or DoD contracting experience highly desired.

REQUIRED CITIZENSHIP AND CLEARANCE:

Must be a U.S. Citizen.

Must be able to pass a NACI for Common Access Card.

The Alaka`ina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries. Eligible employees enjoy a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees.

The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, Kūpono Government Services, and Kapili Services, Po`okela Solutions, Kīkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.

For additional information, please visit

#LI-JS1

#ClearanceJobs