Clinical Trial Operations Manager

Bridgewater, NJ

Contract

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OVERVIEW

Our client is looking for a highly qualified and skilled professional for the role of Senior Clinical Trial Operations Manager (CTOM) in Bridgewater, New Jersey. We are looking for a Senior CTOM with ten years of clinical research experience who wants to be a part of a great organizational culture, is organized and loves the industry.

RESPONSIBILITIES

  • Responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, observational studies, compassionate use and registries) 
  • Responsible for data management activities in compliance with GCPs, SOPs and standards
  • Involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of homogeneous high quality data, in close collaboration with other CSO department representatives (e.g. Medical Operations)

EXPERIENCE

  • A minimum of 10 years of experience in pharmaceutical industry or clinical-related discipline including a minimum of 8 years clinical research experience and 2 years of prior management and/or supervisory experience
  • Strong Project Management and planning skills
  • Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems), processes and SOPs 
  • Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc)
  • Knowledge of industry Data Management standards and practices

EDUCATION

  • Bachelor's Degree required
  • 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.

847-267-1176