Sr. Clinical Studies Analyst (Pediatric Clinical Studies)

Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.

Sr. Clinical Studies Analyst

Responsibilities:

• BARDA Program Office(s) Subject Matter Expert (SME) in clinical development and operations in support of investigational products including vaccines, therapeutics including antibacterial agents to address drug resistant bacteria, biologics, and devices in several therapeutic areas
• Provide scientific and program management expertise in identifying, addressing and coordinating biodefense, pandemic influenza, and emerging infectious disease initiatives relevant to clinical development of assigned vaccine, small molecule, biological, and other medical countermeasures such as diagnostics and medical devices
• Provide SME guidance on the clinical development and operational activities for observational studies and Phase 0 through IV clinical trials, encompassing diverse populations including maternal, pediatrics, elderly, and hospitalized patients.
• Provide SME guidance on clinical development and operations activities for innovative trial design (e.g., decentralized clinical trial, platform trial, master protocol, and use of real-world evidence).
• Provide SME guidance on clinical development and operations activities as a member of Technical Evaluation Panels reviewing funding proposals and requests
• Provide SME guidance on clinical operations during clinical trial activities ensuring resources, budgets, timelines, etc. are planned and executed according to best practices and in a timely manner
• In collaboration with other team members, oversee outsourced clinical trials as part of the Clinical Studies Network (CSN). Serve as an internal project manager/clinical team leader monitoring, assessing, and course-correcting contractors and vendors. Prepare and manage timelines, budgets, and other key deliverables. Develop and implement risk assessment and mitigation strategies. Ensure regulatory processes and guidelines are followed, including co-authoring and reviewing regulatory submissions to the US Food and Drug Administration (FDA)
• Author, review, develop Request for Task Orders (RTORs) and evaluate Clinical Research Organization (CRO) proposals. Provide independent cost, resource, and timeline estimates when requested.
• Provide subject matter expertise on the development, review and comment of other clinical development and operations documents as needed
• Provide guidance and insight into contract proposals, contract extensions, and related documents as requested
• Provide senior level briefings as requested or required
• Provide project development level portfolio management and oversight
• Develop, implement and consciously improve Total Life Cycle Cost (TLCC) efforts
• Author department SOPs based on BARDA SOP processes, current regulations, and guidelines
• Perform additional activities and duties as requested
  
  
  

Qualifications:

• At least 10+ years clinical development and operations experience in positions with graduated responsibilities, including executive-level positions.
• Application of an advanced degree(s) in nursing, biological sciences, public health, medicine or pharmacy or biotechnology and biopharmaceuticals or related field with commensurate experience(s).
• Significant experience related to the management and oversight of clinical studies and programs within vaccine, biologic, therapeutic, and/or antimicrobial advanced development.
• Demonstrated working knowledge of ICH-GCP guidelines with a strong understanding of the clinical and investigational product development approval pathways. Previous clinical/regulatory interactions with the major FDA Centers including CBER, CDER, and CDRH desirable.
• Experience managing late stage (phase 2 and 3) clinical trials, specifically including inpatient treatment trials, clinical trials in pediatric populations or/and other special populations.
• Experience in both CRO and pharma preferred.
• Experience in project management of clinical trials, reviewing vendor invoices.
• Ability to work collaboratively with others both internally and externally.
• Strong business acumen and analytical skills.
• Excellent understanding and demonstrated experience of Human Subject Protections and oversight.
• Strong scientific writing skills.
• Strong interpersonal skills.
• Ability to travel domestically and internationally as requested/needed.
• Experience working on Federal Government contracts.
  
  
  

Tunnell is proud to be an Equal Opportunity / Affirmative Action / Female / Minority / Disabled / Veteran Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, child-birth, or related medical conditions), national origin, ancestry, age, disability, family care status, veteran status, marital status, military status, sexual orientation, gender identity, or any other characteristic protected by law. Tunnell makes reasonable accommodation for persons with disabilities to apply for employment.

Please be advised that some of our client contracts, including contracts with the federal government, require us to validate that our employees and contractors are fully vaccinated against COVID-19, subject to legal requirements. If you are selected for this role or assignment, you will be required to confirm that you are fully vaccinated or engage in an interactive dialogue with Human Resources to determine if you are eligible for a religious or medical exception, and whether making such an exception would pose an undue burden or undue risk of harm.