East Hanover, NJ
Our client is looking for a highly qualified and skilled professional for the role of Clinical Manager in East Hanover, New Jersey. We are looking for a Clinical Manager with at least two years of clinical research experience who wants to be a part of a great organizational culture, is organized and loves the industry.
- Ensuring all operational trial deliverables are met according to timelines, budget, procedures and quality standards, development of study tools, guidelines and training materials
- Management of clinical study material, implementation of issue resolution plan
- Support preparation of clinical outsourcing specifications and manage vendors
- Support the development and tracking of trial budget
- Prepare training materials and presentations related to the planning and conduct of the trial
- Management of the trial master file
- Manage interactions with the CPOs and/or the CTT
- Support management of trial allocation and feasibility
- Responsible for coordination of activities leading to site initiations, (including FPP, RIS, etc.)
- Assist in the oversight of the data review process
- Support in trial close out activities including end of trial checklist
- Responsible for implementation of best practices within Global Clinical Operations and could serve as a subject matter expert (SME)
- May participate in the on-boarding, mentoring and training of new staff
- Minimum of two years of experience in clinical research
- Knowledge of Good Clinical Practice
- Basic knowledge of clinical trial design
- Understanding of the overall drug development process
- Basic knowledge of principles for trial budgeting
- Basic knowledge of Therapy Area preferable
- Bachelor’s Degree or equivalent qualification in life science or healthcare
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.