Principal Clinical Operations Specialist - Oncology Translational Research
Location:
Spring House , Pennsylvania
Posted:
April 02, 2017
Reference:
2951170315/1-en-us

Janssen R&D, L.L.C. is recruiting for a Principal Clinical Operations Specialist - Oncology Translational Research to be located in Springhouse, PA or Raritan, NJ. 

 

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. 

 

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

 

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

 

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

 

The Principal Clinical Operations Specialist – Oncology Translational Research is responsible for facilitating the development and institution of biomarker plans for the evaluation of biological therapeutics in clinical development.  As a biomarker clinical team and study team representative, the primary responsibility of the Principal Clinical Operations Specialist will be to implement program specific biomarker strategies in clinical trials while contributing biomarker related information to the preparation of clinical documents such as clinical protocols, clinical study reports and early development plans. They will also contribute to program and study specific biomarker plans for clinical stage gate review presentations and for other approval meetings.  They will work closely with the biomarker lead on the CDT to identify and propose relevant biomarker assays (internal or external) to achieve the biomarker objectives of the program. They will closely work with representatives from other functional areas, such as Global Clinical Operations (GCO), clinical teams, medical writers, biostatistics and data management.  Further, as operational representative for the clinical trials, the Principal Clinical Operations Specialist will present biomarker plans at investigator meetings and provide training to trial managers and site monitors. They will oversee and contribute information regarding biomarker sample collection and other procedures in synopsis, lab manual, vendor scope of work documents, laminated training materials and in informed consent forms for the sites. They will evaluate and implement new assays and relevant technologies as needed while maintaining an interface with commercial laboratories for assay development and assay transfer for implementation in clinical trials. The Oncology Translational Research Principal Clinical Operations Specialist is also responsible for supporting the Human Resources Planning (HRP) programs including management and staff development and training to meet current and future needs.

 

Responsible for, but not limited to:

  • In collaboration with Translational Research Leads, represent Biomarker community in clinical teams, facilitate the development and implementation of the biomarker plan, contribute relevant information, prepares documents (protocols, reports, stage gates, etc.) and identifies qualified vendors (includes performing due diligence and overseeing their management)
  • Contribute to identifying logistics of biomarker plans
  • Seek to implement improvement in all biomarker related processes
  • Develop solutions and plan of action for a wide range of operational issues
  • Maintain current knowledge of applicable regulations pertaining to sample logistics
  • Collaborate with respective functions necessary to support clinical trials
  • Manage sample/result logistics and operations
  • Interface with lab vendors, establish relationships, facilitate contracts and due diligence
  • Provide completed protocol related documents to clinical teams (protocols, ICFs, CRFs, CSRs, etc.)
  • Work with study lead to reconcile queries, address regulatory issues, manage labs, oversee data/result quality, qualify labs and provide literature searches when necessary
  • Lead analysis of complex issues and develop appropriate solutions
  • Relationships with Contacts Inside the Company: Translational Research leads, members of oncology clinical teams and Clinical Development teams, Global Clinical Operations and laboratory staff
  • Relationships and Contacts Outside the Company: Biomarker testing labs, Central labs, Investigators, Consultants and Opinion Leaders, Contract Research Organizations, and Vendors.
  • May lead or mentor junior clinical operations specialists as needed
 


Qualifications
  • A minimum of a Bachelor’s degree is required.
  • A minimum of and 6 more years industry-related experience, with experience in clinical scientific background, clinical operations in research setting.
  • Prior experience in Biomarker Research and translation research is strongly preferred.
  • Strong knowledge and understanding of clinical research, ICH GCP, GLP, data management, and regulatory and legal issues related to acquisition of samples is required.
  • Strong understanding of global shipping and clinical regulations is preferred.
  • Strong ability to write work guidance and author SOW’s or SOP’s  or scientific document review is required.
  • Good understanding of human physiology, pharmacology and biomarkers is required.
  • Functions independently within an environment that relies heavily on effective communication and collaborating in a matrix


Primary Location
United States-Pennsylvania-Spring House
Other Locations
North America-United States-New Jersey-Raritan
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
2951170315

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