Clinical Research Manager, Vaccines

Ocugen, Inc. Malvern , PA 19355

Posted 2 months ago

Job Purpose

The Clinical Research Manager drives and oversees the operational execution of clinical studies. This individual is responsible for the delivery of clinical studies according to agreed cost and timelines while ensuring patient safety and data integrity and quality.

Duties and Responsibilities

  • Develops and directs clinical trials and operational activities and manages their execution to ensure completion according to project timelines and budget.

  • Leads the study execution team ensuring that studies are conducted in adherence to study protocols, applicable SOPs, ICH/GCP guidelines and government regulations.

  • Reviews and contributes to development of protocols, amendments, case report forms and clinical research reports. Develops informed consents and may contribute to development of annual reports and investigational brochures.

  • Drives the identification, assessment, and qualification of clinical research sites. Ensures training of all investigational sites including planning of Investigator Meetings and development of site training materials.

  • Develops study operational documents which may include timelines, enrollment projections, and study plans. Tracks performance relative to timelines and projections and ensures compliance with study plans.

  • Works collaboratively with internal CRAs to ensure oversight of site initiation, interim monitoring, and site closure activities. Ensures the TMF is developed, maintained, reconciled, and archived.

  • Assists in the identification and selection of CROs and clinical vendors. May manage the RFI and RFP process.

  • Manages clinical vendors including CROs tracking of deliverables to ensure they are within timeline and budget.

  • Provides study status updates to senior management and escalates study risks, as applicable.

  • Works collaboratively with colleagues in Quality Assurance to develop and administer a study audit plan.

  • Works collaboratively with colleagues in Finance to forecast, phase and manage study budgets.

  • Ensures timely delivery of data for external safety board reviews as applicable.

  • Proactively identifies risks, developing and implementing mitigation plans as applicable.

  • May assist in developing policies and procedures (SOPs).

  • Additional tasks and projects as requested.


  • BA/BS degree, in life sciences.

  • 5+ years of progressive clinical research experience in the biotechnology/pharmaceutical industry with 2+ years of experience as a Clinical Research Manager.

  • Must have CRO/vendor management experience.

  • Experience in Vaccines and/or advanced therapy studies in Phases 1-3 highly desired.

  • Strong knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical studies.

  • Demonstrated attention to detail and outstanding organization skills.

  • Self-motivated with a commitment to high quality, on-time deliverables.

  • Excellent communication and collaboration skills with a team-oriented approach.

  • Experience with eTMF, CTMS and EDC.

  • Demonstrated ability to identify and resolve issues and effectively manage timelines.

Working conditions

This position operates in an office setting and may include 20% of travel to visit sites, vendors or CROs. Job may require incumbent to be available outside of normal hours to handle priority business needs.

Physical requirements

This is a largely sedentary role.

Direct reports


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Scientist CarT Cell Based Assay Analytical DevelopmentCell & Gene Therapy Vaccines

Johnson & Johnson

Posted 3 months ago

VIEW JOBS 8/21/2021 12:00:00 AM 2021-11-19T00:00 Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Scientist, CAR-T Cell Based Assay, Analytical Development -Cell & Gene Therapy, Vaccines. The position will be located in Malvern, PA. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are seeking to hire a highly energetic and collaborative, Scientist to join our Cell & Gene Therapy, Vaccines analytical development team. Key Responsibilities: Lead development, qualification, validation and transfer of new and existing analytical methods. Drive efficiencies; incorporate innovation into existing methods. Author protocols and reports, as well as perform and coordinate testing to support analytical development, manufacturing process development, process validations, and manufacturing investigations across functional groups Author analytical sections of regulatory submissions that support regulatory filings including INDs and BLAs Provide technical support to QC laboratories, and assist in investigations Accurately capturing of data in a timely manner, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements is expected. Qualifications Education: Ph.D. in biology, immunology or other relevant scientific field with at least 2 years of relevant experience or Master's degree, with at least 6-7 years of relevant experience, or a Bachelor's degree with at least 10 years of experience. Experience and Skills: Required: Experience in development of cell-based analytical methods is required. Expertise in immunological techniques is required (ex. mammalian cell culture, immunological functional assays, ELISA). Preferred: Hands-on experience with CAR-T or other cell and gene therapy products highly preferred. Knowledge of analytical method development of potency assays, in-vitro tumor killing assays, binding assays and/or residual impurity assays is preferred. Experience working in a cGMP environment is preferred. Knowledge of method robustness, DoE, method design and familiarity with assay validation parameters is helpful. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-Pennsylvania-Malvern-200 Great Valley Parkway Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2105944009W Johnson & Johnson Malvern PA

Clinical Research Manager, Vaccines

Ocugen, Inc.