Job Description

Overview

We are seeking a Scientific Program Manager to support the National Institutes of Health’s (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference.

CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.

Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Responsibilities

• Provide pertinent information for the efficiency of the Vaccine Immunology Program’s End point testing function in coordination with the Chief, Vaccine Immunology Program, management, and the core function leads.
• Assist in the performance of Quality Assurance duties.
• Interface and collaborate extensively with clinical researchers and clinical research administrators.
• Provide support to management and QA Manager in tracking and responding to deviations and CAPA.
• Coordinate with the Testing Facility Manager, Federal Task Leader, and Chief to assign testing pipelines and ensure reagents and materials are available.
• Maintain and oversee all master document inventories, word documents and drafts with the Federal Task Leader and relevant GCLP staff.
• Review study documentation with management to ensure completeness, create digital copies and hard copy folders per appropriate requirements.
• Maintain digital and physical archives with proper disposal of documents according to record retention guidelines.
• Prepare appropriate documentation and respond to document requests for GCLP inspections and internal/external audits.
• Generate study numbers to uniquely identify all clinical and non-clinical study activities undertaken by the program.
• Develop and maintain the coordination of the clinical trial testing master schedule with the list of ongoing activities including clinical trial study plans, assay qualifications, assay method evaluations.
• Create training materials and coordinate with the Federal Task Leader to initiate trainings that are study-specific for GCLP compliance.
• Assist other project managers in ensuring the completeness of all clinical study plans and provide guidance.
• Facilitates the proper level of regulatory compliance for each study, preparing quality-related documentation and addressing quality-related findings.
• Provides close-out guidance for completed clinical studies and presents them to management and Quality Assurance for review and archiving.
• Review the overall day-to-day management of the Vaccine Immunology Program portfolio of analyses and organize testing plans with the stakeholders.
• Liaise with the core elements of the Vaccine Immunology program analytical clinical testing laboratories for the provision of resources: funding, analytical reagents, method optimization and novel assay development suitable to vaccines and biologics.
• Serve as the Subject Matter Expert (SME) representing the Vaccine Immunology Program on project teams and high-level clinical trial meetings at the VRC and external collaborators.
• Identify gaps in processes and potential areas for improvement through the Vaccine Immunology Program’s testing pipeline.
• Coordinate and author Vaccine Immunology Program’s “Analytical Plans” which communicate timelines and tests (including statistical considerations) that are to be completed for each clinical trial analysis.
• Serves as the Vaccine Immunology Program’s information coordinator.
• Originates, formulates, and disseminates project information, assessments, and evaluations to ensure that team members are properly apprised of progress and that members' views concerning the project activities are properly disseminated to integrate project activities across the team.
• Assists in developing, characterizing, and transferring assays to collaborating laboratories or clinical research organizations.
• Serves as a recognized authority for immunogenicity, antigenicity, and anti-drug antibody methodology, applying expert knowledge and understanding of the product development process, requirement of reagents for method optimization and novel assay development.
• pertinent to biologics and vaccines, to the design and conduct of projects where the specifics of the project are difficult to determine in advance.
• Provides significant and innovative recommendations for advancing the project and/or methods used.
• Develops or refines new solutions to problems that have significant impact on existing program policies and/or procedures. Anticipates major problems and recognizes future program needs to accomplish the program’s mission.
• Monitors and assesses the status of projects as they progress. Monitors deadlines and other benchmarks to ensure that VRC activities are meeting stipulated obligations. Disseminates information to the team on the status of activities issues/problems or opportunities to meet expected timelines.
• Applies expert scientific knowledge of the assay development process to guide team meetings and other interactions to clarify critical problems, to develop proposed solutions to problems or issues, to resolve gaps in skills or capacity needed to accomplish the work.
• Facilitates the resolution of conflicts among the team’s members who represent different organizational groups with varying interests or concerns that may conflict with the project’s timetables, scientific requirements, availability of staff and/or staff time, available resources, sequencing demands, etc.
• Applies situationally appropriate project management practices to guide teams to successful completion of the project, to keep activities on schedule and to facilitate an effective project that best meets VRC and NIAID goals. Provides guidance or support to team members collectively or individually.
• Record meeting notes and action items to be shared with the program and its collaborators for effective communication.

Qualifications

• Master’s degree in Biology or Immunology is required.
• Minimum of 8 years of experience in the pharmaceutical, vaccine, biologics, or similar industry is required.
• At least 10 years of experience in R&D, immunological assay development, is required.
• Experience concerning Phase I/II/III method development for clinical trials is preferred.
• Must have experience managing both scientific and organizational information. At least two years’ experience is required in coordination, planning or cross-functional position, project management experience is preferred.
• Minimum 2 years’ experience in managing scientific and organizational organizations.
• Experience in analysis of protein expression and proteomics characterization, and with Mesoscale Discovery (MSD) and Singulex methodology. Anti-drug antibody methodology also required.
• Understanding of protein analysis with experience in quantitative and qualitative protein analysis for existing and novel assay development.
• Knowledge of the requirements and experience developing, qualifying and/or validating assays for products and managing method transfers between laboratories.
• Experience with vaccine / therapeutic protein development and regulatory requirements such as GLP/FDA practices.

Physical Requirements:

More information on this position, including the physical requirements, can be found at

Please submit your resume online at . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.

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