30 days old

Clinical Trial Program Manager

MSC
Myrtle Point, OR 97458

Overview

Medical Science & Computing (MSC), a Dovel company, is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.

 

We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!

 

Duties & Responsibilities

MSC is searching for a Clinical Trial Program Manager to provide support to the National Institutes of Health (NIH).  This opportunity is a part-time position with MSC and will be located in Monrovia, Liberia.

 

  • Actively manage the Liberia-US Ebola Virus Disease (EVD) vaccine clinical trial; provide the sponsor and IRB with documentation required to conduct the clinical research; develop protocol and clinical related components of the clinical trial; supervise program staff; manage the program progress; prepare and publish scientific manuscripts.
  • Secure IRB approval of clinical documents required to conduct the clinical research (i.e., protocol, investigators brochure, informed consent form, recruitment procedures, etc.). Ensure adherence to protocol requirements; adhere to local IRB requirements and applicable regulations; protect the rights, safety, and welfare of subjects; ensure the integrity of data generated at the various vaccine sites; and direct the conduct of the clinical trial according to national regulations, guidance documents, and institutional guidelines, procedures, policies and/or processes.
  • Work collaboratively with the NIH Principal Investigator (PI) to complete the study protocol; partner with regulatory entities to ensure timely submission; partner with institutions to manage the available resources; partner with the legal group to review partnership agreements; partner with compliance and QA staff to ensure that national standards and regulatory requirements are met, partner with stakeholders to ensure that the vaccine trial needs are met and practices are compliant in a controlled environment; partner with the clinical trials teams in both Liberia and the US to effectively facilitate the completion of the vaccine clinical trials.
  • Significant investment in mentoring junior colleagues, young investigators, and the newest cadres of Liberians, in infectious disease epidemiology, clinical research and guidelines, research methods, good clinical practice(s), ethical and regulatory guidelines, documentations, and adherence to study protocols.
  • Serve as one of the key bridges between the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) and the Ministry of Health (MoH). Regularly liaise with the senior management of the MoH to provide updates on PREVAIL related activities, navigate the bureaucratic systems to support PREVAIL initiatives, and set appointments for junior staff to provide progress reports, where applicable. Similar roles are performed with other partners, where applicable, in Liberia, like, for example, CDC, Partners in Health (PIH), WHO, etc.
  • Liaise with the national legislature, especially the individual and/or joint sub-committees on Health in the House of Representative and/or the Senate to regularly update them, formally and/or informally, on PREVAIL related activities, progress and challenges to-date, and potentially address concerns, where applicable.
  • Regularly identify capacity building and training opportunities for junior colleagues and staff of PREVAIL; organize, coordinate and facilitate training workshops; identify suitable conferences and negotiate slots for PREVAIL staff; and identify gaps and needs for training opportunities, among others.
  • Identify suitable partners for collaborations with PREVAIL based on strategic synergism, collaborate with partners to develop and submit grant applications to funding agencies, identify and strengthen networks for PREVAIL, and ensure collaborative initiatives support added values and sustainability for PREVAIL, etc.
  • Motivate and support junior colleagues with presentations at conferences, stimulate scholarly initiatives by collaborating with colleagues within and outside of PREVAIL to generate and submit scientific manuscripts for publications in peer-reviewed journals to showcase PREVAIL work, and encourage technical team members to publish, etc.
  • Disseminate updates from PREVAIL to the general public through press conferences and briefings at the Ministry of Information, Cultural Affairs & Tourism (MICAT), and occasionally provide updates to the print and broadcast media, whenever called upon, regarding PREVAIL related activities, progress and outcomes.
  • Actively participate on PREVAIL Steering Committee (PSC) and the Executive Committee (EC) to identify, support and strengthen scientific and administrative initiatives at PREVAIL, participate and support strategic planning and directions at PREVAIL, identify gaps and challenges at PREVAIL and provide suggestions to ameliorate the perceived gaps and challenging situations, and provide strong scientific leadership at Technical Team Meetings, etc.

Requirements

 

  • M.D. or D.O from an accredited university required. Active license to practice medicine required.
  • Extensive experience in public health, infectious disease research, biomedical research and/or postdoctoral research required.
  • Experienced in protocol development and execution. Well versed in all aspects of the protocol lifecycle including initial IND submission, IRB submission, continuing review applications, protocols, protocol amendments, annual reports, and protocol inactivation.
  • Strong program management and leadership skills required. Must be able to lead multidisciplinary teams, create and assign tasks, supervise and mentor senior and junior level staff, and plan and manage technical aspects of projects.
  • Experience advising on research and providing
  • Excellent communication, presentation and interpersonal skills both oral and written. Must be able to disseminate information and serve as a liaison to various groups within a scientific community.

 

Medical Science & Computing (MSC), a Dovel company, is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Categories

Posted: 2020-07-07 Expires: 2020-09-05

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Clinical Trial Program Manager

MSC
Myrtle Point, OR 97458

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