Health & Wellness Solutions, Clinical Research Lead
Location:
New Brunswick , New Jersey
Posted:
March 07, 2017
Reference:
8378170127-en-us

Johnson & Johnson Health and Wellness Solutions is a recently announced center of excellence for the Pharmaceutical, MD&D and Consumer sectors, focused on healthcare consumer engagement and behavior modification, leveraging behavioral science, healthcare analytics, and a common digital/IT platform. 

Johnson & Johnson Health and Wellness Solutions will serve as an enterprise-wide group responsible for harnessing a J&J portfolio of capabilities to deliver innovative J&J enterprise solutions for J&J products in order to deliver improved health outcomes.  

Johnson & Johnson Health & Wellness Solutions is recruiting for a Clinical Research Lead to be based in New Brunswick, New Jersey.
 
Johnson & Johnson Health and Wellness Solutions will also partner closely with the Johnson & Johnson Unrivaled Products & Solutions team, the Consumer sector retail team and each sector’s strategic customer and franchise account groups to help guide the development of offerings to payer, provider and retail customers globally.
 
The Research Lead is accountable for the day-to-day operations and execution of all Johnson & Johnson Health and Wellness Solutions (JJHWS) research activities to ensure that they meet all regulatory requirements and meet all research project operational milestones. Major Duties & Responsibilities include but are not limited to:
 
  • Track adherence to protocol, Good Clinical Practices, Standard Operating Procedures while following clinical monitoring plan.
  • Responsible for clinical trial date quality provided by both vendors and sites.
  • Responsible for reviews and follow up of audit issues while communicating outcome/progress to Study Execution Team (SET) to ensure proper resolution
  • She/He will work closely with various parties to track protocol deviations.
  • The Clinical Research Lead will work closely with data management in the creation and execution of protocol deviations.
  • Lead trial risk mitigation activities through process while escalating issues to functional leads and senior management as appropriate.
  • In conjunction with the Director the Clinical Research will be responsible for the development and oversight of clinical trial plans including but not limited to-site monitoring plans, quality management, co monitoring plans, risk mitigation, clinical supplies management.
  • She/He will be responsible for the creation and maintenance of study specific informed consent forms.
  • Manages department teams and/or taskforces to improve processes for trial execution.
  • Writing and creation of study documentation that includes protocols and study documentation

Qualifications
Qualifications:
  • Three years of relevant experience required.
  • Experience managing clinical vendors including CRO’s.
  • Prior Clinical site monitory experience is highly preferred.
  • Experience managing research projects and budgets is required
  • Clinical Research knowledge and cross-functional understanding of clinical trial methodology is required.
  • Proficiency and strong understanding of GCP (Good Clinical Practices) is required.
  • Up to 20% travel is required
  • Experience within the Pharmaceutical, Biotech, CRO, or Epidemiology field is required.
  • The ability to work with various oversight bodies is required
  • The ability to manage and supervise a staff of contractors and/or fulltime employees is required.
  • The ability to liaise with external entities such as Institutional Review Boards and Clinical Vendors is required

Primary Location
United States-New Jersey-New Brunswick
Organization
J&JHlth&WellSolutions,Inc (6173)
Job Function
R&D

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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