Quality Management Specialist

Job Family:

Administrative Services (Digital)

Travel Required:

None

Clearance Required:

Ability to Obtain Public Trust

What You Will Do:
We are currently searching for a Quality Management Specialist. This role will ensure industry standard operations and quality management of clinical trials. This is a full-time opportunity supporting our office in Bethesda, MD.

• Review the Pre-Implementation checklist to identify gaps and make recommendations and modifications.

• Evaluate clinical trial operations at research coordinating and performance sites, advise on quality control, quality assurance and quality improvement procedures.

• Advise the research team with developing quality management procedures addressed in pre-implementation requirement materials; evaluate the documents for quality, usability, and feasibility.

• Assist the research teams with incorporation of quality management into clinical trial operations by developing tools that include essential documents; manuals of operations; Quality Management Plans (QMS); Clinical Data Management Plans (CDMP); study staff qualification documentation, training plans, and completion logs.

• Assist the research team by reviewing, providing feedback and assisting in the modifications of quality management SOPs submitted by the research teams; evaluating the actual practice to ensure that trials are conducted, and data are generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). 

• Review and verify that the pre-implementation/implementation study team documents and SOPs address NIH and regulatory requirements for clinical trials; provide recommendations for improvement to study teams and verify deficiencies are appropriately addressed.

• Provide consultation and develop tools for the study site that coordinates research activities, including subsites, to monitor trial operations, progress, data integrity.

• Conduct Site Initiation Visits and train study coordinators/delegated study team staff

• Develop a comprehensive plan and user-friendly tools for site initiation visits.

• Conduct evaluations of the coordinating and performance sites’ infrastructure, organizational structure, communication procedures, resources, staff quality and training for the conduct of each clinical trial

• Verify the site is prepared to initiate the clinical trial, provide recommendations for activation (allowing the initiation of enrollment), review and evaluate:

  • Availability and delegation of appropriately trained clinical and technical personnel to conduct the clinical trial,

  • Completion of clinical trial required training, clinical research infrastructure and resources for the screening, enrollment, intervention administration, endpoint evaluations, safety monitoring, and follow-up of study subjects.

  • Availability, appropriate storage, and accountability of the study intervention at site

  • The recruitment and retention plan and feasibility for enrollment target goals, including efforts to enroll underrepresented populations such as underrepresented minorities (if scientifically appropriate) when new sites are proposed by research teams.

• When a major deficiency is observed, provide a verbal debriefing and resolution advice and a written report of the observation and recommendations.

• Train the study coordinators/delegated study team staff to independently perform effective subsite initiation visits and interim subsite visits to monitor trial implementation, conduct, and data integrity.

• Provide evaluations reports identifying issues and recommended solutions to address issues.

What You Will Need:

• Bachelor’s Degree in a Science related discipline.

• A minimum of Eight (8) years of progressive global quality and/or regulatory compliance in pharma/biotech and medical device industries.  

• Hands-on experience in clinical quality operations and quality systems development.

• Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines, quality principles, inspection preparation and hosting, risk management and other global regulatory requirements governing clinical research.

• Demonstrated experience developing and managing GxP Quality Systems through clinical phases of development to product approval highly desired.

• Extensive experience supporting and overseeing clinical trials.

• Direct experience with FDA or other health authority inspections of sponsor, investigator site(s), and/or CRO(s) preferred. 

• Self-motivated with the ability to take initiative, ownership and manage responsibilities while shifting priorities quickly under tight timelines.

• Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.

What Would Be Nice To Have:

• Masters in a Science related discipline preferred. 

• Auditor Certification preferred.

The annual salary range for this position is $115,200.00-$172,800.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.

What We Offer:

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

• Medical, Rx, Dental & Vision Insurance

• Personal and Family Sick Time & Company Paid Holidays

• Parental Leave

• 401(k) Retirement Plan

• Group Term Life and Travel Assistance

• Voluntary Life and AD&D Insurance

• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts

• Transit and Parking Commuter Benefits

• Short-Term & Long-Term Disability

• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities

• Employee Referral Program

• Corporate Sponsored Events & Community Outreach

• Care.com annual membership

• Employee Assistance Program

• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)

• Position may be eligible for a discretionary variable incentive bonus

About Guidehouse
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 an 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.