Clinical Trial Operations Manager
Our client is looking for a highly qualified and skilled professional for the role of Clinical Trial Operations Manager in Bridgewater, New Jersey. We are looking for a Clinical Trial Operations Manager with at least 12 years of experience who wants to be a part of a great organizational culture, is organized and loves the industry.
- Responsible for serving as clinical trial leader for a large-scale multi-country trial (Phase IV or Post Marketing)
- Provides input into identifying implications of study progress on overall timeline goals and conduct plans
- Provides input into content and execution of investigator meetings and may present selected topics
- Provides point of contact for site questions relating to study conduct issues
- Participates in the implementation of key organizational process improvement initiatives
- Responsible for protocol preparation, generation of manuals for trial support committees and other trial documentation
- Lead a multi-disciplinary team responsible for study completion
- Has Data Management experience, including vendors oversight, medical review, (S)AEs reconciliation, (micro) planning and management of study milestones, Data Base Lock (DBL) and Interim Analysis (IA) lock
- Excellent communicator
- Experience in Clinical Trials or Clinical Project management
- Bachelor’s Degree, RN or equivalent
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.