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, NJ. We are looking for a Clinical Trial Operations Manager with 5+ years of experience in clinical research who wants to be a part of a great organizational culture, is organized and loves the industry.
- Provide management and oversight of clinical trials
- Lead the Clinical Trial Team (CTT) (i.e., CRAs/CROs, Data Management, Pharmacovigilance, Clinical & Exploratory Pharmacology Sciences, Biostatistics, Pharmacokinetics, Clinical Supplies
- Manage the study according to Good Clinical Practices (GCPs) and local and/or national regulations
- Collaborate with team members on a day-to-day basis; in particular, build a strong collaboration with the study Data Manager (DM) and the Clinical Study Director (CSD)
- Anticipate bottlenecks in all steps of the study and development/implementation of counteractive measures
- Solve or coordinate the resolution of issues during conduct of the trial
- Develop and review specific study-related documents
- Develop and coordinate the study budget, including invoice validation
- Contribute to contract process
- Manage investigational product supplies (ordering, packaging, and shipment)
- Participate in and contribute to internal audits, if applicable
- Serve as main contact for clinical sites and other outsourced activities
- Manage local MT (CSUs) when applicable
- Manage outsourced centralized activities when applicable (Central Lab)
- May perform studies following some Phase 2-3 processes when applicable (multicenter-multicountry Phase 2a trials)
- Collect, synthesize, report, file and prepare archiving for clinical trial activities
- Manage CRO/study sites
- Escalate quality issues and delays in deliverables, propose solutions, request and ensure follow-up actions
- Assess CRO performance by completing CRO post services assessments
- Conduct yearly CRO assessment, if applicable
- Manage outsourced/sub-contracted monitoring activities, when applicable
- Lead study-specific training
- Manage performance of monitors
- Review and approve all visit reports
- Conduct field monitoring activities, if required
- Set-up and manage site visits (Site Initiation Visit, Interim Monitoring Visits, Closure Visit) including in-house preparation such as data listings review
- Previous experience with medical terminology (basic knowledge in medicine is preferred, including laboratory procedures/techniques and biological knowledge) and GCP/ICH Guidelines
- General understanding of R&D processes including the principals of study design and execution
- 5+ years minimum in clinical research, including an international background
- Field monitoring experience or related experience is required (approximately 3-5 years).
- Strong English communication skills (verbal and written) if English is a second language.
- Clinical Trials Management or Project management experience (approximately 3-5 years) and recognized in cross functional operations.
- Previous Phase I experience preferred
- Knowledge of data management activities
- Experience with management of outsourced activities
- Experience with various computer systems/database; a willingness to learn new systems/databases
- U.S.: Bachelor's Degree + 8+ yrs. laboratory or medical experience
- Europe: BAC +4/5 (Master's Degree)
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.