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SENIOR CLINICAL OPERATIONS SPECIALIST - ONCOLOGY

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Job Description


POSITION SUMMARY: This Senior Clinical Operations Specialist is responsible for managing the oversight and implementation of biomarker strategic objectives as directed by the Biomarker Leads in clinical trials including, sample quality, timeliness, biomarker administrative needs (budget, presentations and study documents), continuous process improvement, and change management. This role is responsible for all biomarker sample logistics within clinical trials from study start up through final close out visit ensuring that all regulatory and organizational requirements are met.

 
 

ESSENTIAL FUNCTIONS: (Core Responsibilities - See Attachment II)

  1. Assist Translational Research Lead in the oversight, management and implementation of the BM clinical plan
  2. Oversee and manage vendor relationships/due diligence assuring quality data & training of sites
  3. Collaborate with GCO/GDO/PK overseeing sample/result management
  4. Assist TR lead with study related documents, training of sites, queries, regulatory issues/concerns, management of labs, interfacing with BioBank staff and performing literature searches
  5. Defines elements of program strategies  Proactively investigates and develops improvements to existing processes
 
 

OTHER RESPONSIBILITIES / DETAILED DUTIES:

  1. Functions independently within an environment that relies heavily on effective communication and collaborating in a matrix.
  2. Able to solve problems within own area of expertise.
  3. Provides perspective and provide sample logistic information.
  4. Provide input to the broad protocol design and review cycle.
  5. Directs work of junior colleagues.
  6. Represent Biomarker Community in cross-functional meetings and teams on an ad hoc basis
  7. Display effective written and verbal communication skills. Demonstrates good judgment in what and when information/opinions are communicated. Actively seeks input, listens, and understands. Shares accurate information with peers, supervisor, or work team. Prepares reports. Delivers clear and effective presentations..
  8. Proactively seek to learn. Identify sources of knowledge independently to enhance personal growth. Share experience with others willingly
  9. Clear communication skills


Qualifications

Education:

  • Bachelor’s degree and 6+ years industry-related experience.

Related Experience:

  • Strong knowledge and understanding of clinical research, ICH GCP, GLP, data management, and regulatory and legal issues related to samples.
  • Strong understanding of shipping  and clinical regulations
  • Strong ability to write work guidance and author SOP’s.
  • Good understanding of human physiology, pharmacology and biomarkers
  • Functions independently within an environment that relies heavily on effective communication and collaborating in a matrix.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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Primary Location
United States-Pennsylvania-Spring House-
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
8422191028