Clinical Operations Program Manager

Location
Rockville, Maryland
Posted
Jan 19, 2022
Ref
2021-10111
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
Position Type
Full time

We are currently searching for a Clinical Operations Program Manager 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 Rockville, MD.

 

Duties & Responsibilities
  • Act as subject matter expert (SME) for all data management activities including proper data entry and tracking, human subject’s protection, data confidentiality and related IT security.
  • Develop and maintain a proficiency in accessing and reviewing clinical study related information from databases used by the program and additional relevant clinical data databases including those of clinical research organization (CRO) awardees, ImmPORT and ClinicalTrials.gov.
  • Provide expertise to sponsor clinical data management projects on multiple complex studies and programs, both internal and performed by supporting clinical research organizations (CROs).
  • Provide technical oversight of CROs performing core data management functions including case report form (CRF)/edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures.
  • Responsible for the oversight of clinical data management study deliverables, evaluating and mitigating data management risks.
  • Provide expertise to assist in CRF and database design.
  • Assist in the development and implementation of data transfer and migration plans relating to transitions between CROs.
  • Perform or oversee development of clinical data management validation plans, data transfer requirements and agreements, and data management plans.
  • Provide expertise in support of developing sponsor data management SOPs, procedures, PWIs, Plans, Guidance and other quality-related documentation.
  • Devise and oversee implementation of quality assessment procedures according to data management plans and other means.
  • Assess the quality of the statistical programming processes through techniques including but not limited to good documentation code review, and testing.
  • Assist with the creation and review of CAPAs related to clinical data management.
  • Review and process clinical trial data to ensure data quality for data analysis.
  • Participate in clinical study data reviews and other activities related to database lock.
  • Participate in multi-party clinical data process development initiatives.
  • Assist in the development of data pathways and system interconnection arrangements.
  • Provide input on clinical data management system enhancements including design, review, performing user acceptance testing and validation supporting activities. 

#LI-DW1

Requirements
  • Master’s degree in a related discipline required. A Ph.D. in a related discipline a plus.
  • At least five (5) years of clinical data management experience is required.
  • Excellent verbal and strong written communication skills are required as this person is expected to interact with team members from various disciplines every day.
  • Excellent analytical, organizational and time management skills required.
  • Thorough understanding and experience with GCP/GxP, Privacy Act and quality requirements are required.
  • A working knowledge of clinical data management tools is required.
  • Experience programming and using Medidata Rave, Oracle Argus and RedCap preferred.
  • Familiarity with clinical trial data standards such as CDISC preferred.
  • Experience in developing eCRFs and clinical databases required.
  • Experience creating and evaluating clinical data management plans and agreements preferred.
  • Experience working within a quality-driven environment is preferred.
  • Experience creating and evaluating SOPs and CAPAs required.
  • Systems validation experience preferred.
  • Knowledge of data systems architecture and structure of data systems is required.
  • Pharmaceutical industry experience a plus.
  • Excellent computer skills, proficient in Microsoft Office, SQL and XML required.
  • Experience with statistical software such as R, SAS, Stata, & SPS preferred.

 

Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.

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.