Clinical Trial Operations Manager IV

Bridgewater, NJ

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Trial Operations Manager IV, in Bridgewater, NJ.  The Clinical Trial Operations Manager provides input into identifying implications of study progress on overall timeline goals and conduct plans. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.

RESPONSIBILITIES

  • Provides input into content and execution of investigator meetings and may present selected topics 
  • With oversight, develops informed consent form and coordinates input
  • With oversight, provides point of contact for site questions relating to study conduct issues
  • Participates in the implementation of key organizational process improvement initiatives
  • Responsible for serving as clinical trial leader for a large-scale multi-country trial (Phases I-IV)
  • Responsible for protocol preparation, generation of manuals for trial support committees and other trial documentation
  • Lead the multi-disciplinary team responsible for study completion
  • Writes and reviews abstracts/manuscripts, etc. for presentation/publication at internal/external meetings

EXPERIENCE

  • 9 to 12 years of experience
  • 2+ years of prior management and/or supervisory experience in coordinating international clinical trials is strongly preferred
  • Strong vendor management oversight experience
  • Global studies experience
  • Experience in Clinical Trials or Clinical Project management
  • Experience with Investigator Sponsored Trials
  • Ability to lead the study team and being able to efficiently work with other CTOMs in the same study 
  • Ability to manage and lead international meetings (e.g. Study Teams)
  • Ability to anticipate, timely escalate issues and to define appropriate action plans
  • Ability to lead transversal projects
  • Capability to challenge decisions/status-quo/requests using risk management approach (e.g. unrealistic timelines, unplanned database snapshot.)
  • Ability to work cross-functionally fostering team spirit and team motivation (e.g. study team or transversal project team)
  • Display stakeholder management skills e.g. ability to manage expectations
  • Excellent communication skills

EDUCATION

  • Bachelor's degree (advanced degree preferred) 


To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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