Manager, Clinical Operations
We are currently searching for a skilled professional to join a well-known client’s team as Manager, Clinical Operations in Parsippany, New Jersey. The Manager, Clinical Operations will manage the conduct of single and multicenter studies, including site selection, development of monitoring plan, communication plan, site budgets, and investigator meeting. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Participate in the development and coordination of protocols, informed consent forms, investigator brochures, clinical study reports, IND annual reports
- Present protocol at investigator meeting
- Develop study-specific EDC system and manage timeline of creation of the database before study start
- Effectively manage the clinical staff (e.g., clinical research associates, administrative assistants) assigned to the study
- Lead and direct the study team, which includes individuals from various clinical and functional departments
- Maintain relevant FIPCUS internal tracking systems, including all clinical study management systems
- Review and approve all study expenditures and bills, coordinating with the accounting department· Maintain ongoing communication with FIPCUS management regarding study progress, enrollment, and any problems encountered during the study
- Trouble-shoot throughout the course of the study to resolve any issues arising at study sites, or with monitors and CROs
- Travel to sites and other facilities as required including some international travel (passport required)
- Ensure that the conduct of all studies follow local or global SOPs and regulatory requirements
- Develop, negotiate and track study budgets
- A minimum of five years of experience, including a combination of pharma and CRO experience; not strictly CRO
- In depth understanding of the drug development process as well as the operational and regulatory aspects of clinical development
- Understanding if ICH GCP guidelines and sponsor responsibilities
- Experience with study start-up, time management, knowledge of study expenditures
- In-depth knowledge of the protocol
- Experience with capturing relevant data in EDC format
- Knowledge of edit checks, writing and answering queries
- Must have experience managing a staff of up to two people
- Vendor management experience required
- Bachelor’s Degree in a health or science related field is required
- RN or BSN strongly 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.