Trial Master File Specialist

Location
Bethesda, Maryland
Posted
Apr 24, 2022
Ref
2022-11356
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

We are currently searching for a Trial Master File Specialist to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is on-site in Bethesda, MD.

 

 

 

Duties & Responsibilities
  • Manage Trial Master File program for all program studies. Develop protocol-specific TMF indexes and plans at trial start, collect and file TMF documents throughout the trial, correspond with TMF CRO support during and after the trial, and ensure QC of final TMF at the end of the trial.
  • Advise, coordinate and plan scientific research activities for Phase I and II clinical trials for investigational vaccines and monoclonal antibodies targeting infectious diseases including influenza, HIV, malaria, etc.
  • Serve as a clinical protocol study team member, will actively engage in protocol planning and development and development and assessment of domestic and international sites.
  • Develop processes and SOPs and other documents to support TMF management.
  • Ensure adherence to processes and SOPs specific to documents under their management.
  • Ensure documents are readily available for audits and inspections.
  • Participate in internal or external audits and regulatory authority inspections as needed.
  • Provide guidance and serve as a TMF resource to colleagues.
  • Draft, edit, and review protocols and operations manuals specific to the research projects.
  • Provide scientific and regulatory guidance and assistance to the program in support of product development.
  • Review and provide input on various research agreements (interagency agreements, clinical trial agreements, etc.) to ensure the program’s needs are met.

 

 

Requirements
  • Master’s Degree in a related filed OR Bachelor’s Degree with applicable job experience may be considered.
  • Regulatory Affairs Certification (RAC) preferred.
  • Minimum five (5) years of experience in the pharmaceutical/biotechnology industry, government, or equivalent, including a minimum of three (3) years clinical document management system experience, preferably with drugs or biologics products.
  • Experience participating in internal or external audits and regulatory authority inspections preferred.
  • Demonstrates knowledge and understanding of GCP, ICH guidelines and, regulatory requirements for clinical research and TMFs.
  • Ability to work independently and as part of a team.
  • Strong organizational skills.
  • Excellent oral and written communication skills.

#LI-EJ1

 

 

Company Description

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.

 

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

 

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

 

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

 

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.