Johnson & Johnson Careers

Clinical Research Manager

South San Francisco, California
Clinical Trial Administration


Job Description

Requisition ID: 8912180806

Alios BioPharma, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Clinical Research Manager to be located in South San Francisco, CA.
 
Johnson & Johnson's Family of Companies are dedicated to addressing and solving the most important unmet medical needs of our time, including: oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.


Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.  Proud to be an equal opportunity employer.

 

 

The Therapeutic Area Early Development Clinical Operations group is a responsible member of the clinical team, dedicated to the development and execution of the clinical and translational strategy and program (scientific, clinical, and operational) of compounds in Early Development. The TA ED ClinOps group provides the operational leadership in planning and delivering study design, protocol development and execution of clinical studies in early development (Phase 0 to Phase 2a) and is accountable for the outcome of the end-to-end (E2E) execution for each assigned clinical project in a timely and cost-effective manner. The TA ED ClinOps contributes to the interpretation and reporting of clinical study results. The TA ED ClinOps is actively involved in and contributes to external collaborations, innovation projects, translational strategy, DAS/TA strategy, and newly defined development or disease area opportunities. 


Clinical Research Manager:

As a core member of the Therapeutic Area Early Development Clinical Operations, the Clinical Research Manager (CRM) will report to a Director within the ED ClinOps in Infectious Diseases and Vaccines Therapeutic Area. The CRM will be responsible for the implementation of clinical trial systems and activities of one or more clinical trial programs.  The CRM will be a key member of a clinical development team that is implementing several early stage clinical programs evaluating investigational drugs in the area of Infectious Disease.


Scope/Key Responsibilities:
  • Responsible for managing operational aspects of study conduct. (Start-up through database lock)
  • Collaborates with Clinical Team to meet corporate goals for assigned program.
  • Competent in clinical study management practices.
  • Responsible for vendor management or collaboration on management with more senior team members.
  • Performs oversight visits to sites as necessary for advancement of program.
  • Assists in data review and package compilation.
 
Essential Job Functions:
    • Thorough understanding of FDA, ICH and GCP guidelines.
    • Perform operational aspects of implementing and managing a clinical trial, with support of manager or senior team member.
    • Ensures timelines and deliverables provided by senior team members are met.
    • Responsible for managing timelines for deliverables such as protocol, ICF, CRF, and Study Manual development.
    • Provides direction to junior team members such as for system entry
    • Creates materials for training such as SIV or investigator’s meetings.
    • Serves as primary contact for most vendors
    • Responsible for development of technical specifications for vendors such as SOWs and Lab Specs.
    • Responsible for review of invoices for accuracy compared to work known to be performed by the vendor, under the guidance of more Sr. Clin ops team members.
    • May also be responsible for resolving discrepancies in invoicing.
    • Liaise with Clinical Supply Manager to ensure delivery of accurate supply needs (Drug/Ancillaries, etc.) on time to study centers or depots as applicable, and for continued study resupply during course of study.
 

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.



Qualifications
Qualifications:
  • A Bachelor’s degree in relevant, scientific discipline is required.
  • A minimum of 6 or more years of relevant professional experience in clinical development, clinical operations, or clinical trial management within the industry is required.
  • Experience in clinical development early development is preferred.
 
Key Attributes:
  • Thorough knowledge and understanding of FDA and EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials 
  • Excellent teamwork, communication, decision-making and organizational skills.
  • Must be flexible and adaptable to the needs of the department
  • Must be able to prioritize multiple tasks. 

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.



Primary Location
United States-California-South San Francisco
Organization
Alios BioPharma, Inc. (6224)
Job Function
Clinical Trial Administration
Requisition ID
8912180806