Careers & MSC, LLC

At MSC, our success depends on the talent and dedication of our employees who are driven to make a difference. We create a culture of learning, innovation, and teamwork and encourage our staff to develop new skills and expertise. We offer competitive pay and excellent benefits. If you require assistance in submitting an application for employment with MSC please call 240-514-4140 or email careers@mscweb.com. Applicants have rights under Federal Employment Laws: Family and Medical Leave Act (FMLA), Equal Employment Opportunity (EEO), Employee Polygraph Protection Act (EPPA).

Medical Monitor

Job Title
Medical Monitor
Position ID
27051427
Duration
Location
Bethesda,  MD
Other Location
Description

Medical Science & Computing (MSC) 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.

 

MSC is currently searching for a Medical Monitor to support the National Institutes of Health (NIH). This opportunity is full-time, and it is on site in Bethesda, MD.

 

Duties and Responsibilities:

  • Design protocol strategy and assist with development of regulatory and study documents.
    1. Design a clinical study to meet the agreed strategic context.
    2. Leads study team in writing the synopsis and background section of the protocol.
    3. Finalize protocols and amendment.
    4. Approve study template informed consent form (ICF).
    5. Coordinate with the study team to review and approve study processes and deliverables.
    6. Participates in development of CRF, statistical analysis plan (SAP), DMC charter and other documents as required by the OCD.
  • Responsible for study conduct in conjunction with clinical operations.
    1. Participate in study management team meetings, Data Monitoring Committee (DMC) and steering committees as required.
    2. Answer safety questions and review the literature as needed, provide input to safety issues and answer questions posed by IRB, IBC, DMC, etc.
    3. Actively interact with investigative sites, respond to protocol/medical questions.
    4. Provide communication(s) to sites across the stud.
    5. Assist sites with subject evaluation and protocol adherence.
    6. Review safety reports to support regulatory notifications and filings.
    7. Participate in vendor selection for IRB, DMC and other outsourcing activities.
  • Study Level Data Review.
    1. Perform review of data generated by data listings or statistical analyses.
    2. Request additional tables or analyses where appropriate.
    3. Review individual data with SAEs and potentially clinically important laboratory test or vital sign abnormalities.
    4. Participate in all reviews and procedures required for database lock.
    5. Review all patient narratives.
    6. Review outstanding medical or GCP issues report and address issues across the study.
  • Provide Study team with medical expertise during key activities.
    1. Answer medical and inclusion/exclusion questions.
    2. Issue resolution.
    3. Audit response.
    4. Study closeout/inspection readiness.
  • Oversee and conduct protocol training; produce relevant and materials.
    1. Deliver protocol training during Investigator meeting and Site Initiation Visit (SIVs).
    2. Create medical training materials for SIVs and study team training.
    3. Provide specific medical/protocol training for Clinical Research Associates (CRAs) and study team.
    4. Develop medical/protocol training for use during Site Initiation Visit (SIV).
    5. Be available to answer questions specific to the protocol during the site start-up process.
  • Participate in safety evaluation and support for the investigational products.
    1. In conjunction with the drug safety team, answer medical/safety questions and resolve medical/safety issues from sites, CRAs and study team; such as questions from sites on protocols. In conjunction with other medical personnel, ensure answers are consistent across all sites and studies.
    2. Participate or lead safety issue workups.
    3. Review study and individual subject safety for assigned studies and present findings at quarterly drug safety reviews.
  • Interact with regulatory groups and internal auditing groups on a study level.
    1. DMC Interaction.
    2. Accountable for providing a response to regulatory agency inspection observations and internal audits.
    3. Support regulatory update.
    4. Assists with rest of world regulatory activities to support study conduct and future marketing approval strategy and execution.
  • Contribute to, review, and edit Clinical Study Reports (CSR).
    1. Approve patient narratives.
    2. Conduct decision point preparation for senior management.
  • Contributes to IB updates for the project.
  • Assists in development of scientific meeting abstracts and presentations as well as manuscripts.
  • BLA submission team.
    1. Member of the team with specific responsibilities including CSR as well as summary documents which may be assigned.
    2. Assists in oversight of other BLA requirements such as clinical pharmacology requirements for the drug.
  • Performs other duties as required.

     

 

Position Requirements:

  • M.D. degree or equivalent with + years’ experience in clinical trials and drug development.
  • Clinical research experience in a pharmaceutical or CRO environment a plus.
  • Demonstrated experience conducting of clinical studies supporting cancer research.
  • Experience interacting with FDA.

 

Medical Science & Computing is an Equal Opportunity/Affirmative Action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Openings
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