Clinical Trial Operations Manager IV - 7116421
Our client is looking for a highly qualified and skilled professional for the role of Clinical Trial Operations Manager IV in Bridgewater, NJ. We are looking for a Clinical Trial Operations Manager IV with 7 years of Trial Operations Management experience, and five years oncology experience, who wants to be a part of a great organizational culture, is organized and loves the industry.
- Provide oversight of a study to ensure progress according to study timelines and budget
- Possibly lead or be a support trial manager for a study team. Support the study team including representatives from CSUs/affiliates/CROs, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics and other relevant departments) for the operational aspects of the study. Liaise with clinical purchasing to prepare the RFP (request for proposal), review vendors specifications and oversee vendor activities and deliverables (i.e., Central Lab, IVRS, data management, external reviewer/adjudicator, meeting planners, ePRO, couriers, etc.). Liaise with coding and clinical application representatives when applicable
- Ensure proper documentation/availability
- Contribute to the extended synopsis, protocol, amendments, and WSI (operational sections) development and review to ensure operational feasibility; Definition of the Case Report Form content and testing of the end product. Develop study-specific procedures and write the Monitoring Plan, contribute to the CRF completion guidelines, the Data Review & Surveillance Plan and/or other operational documents in conjunction with the STM. Review other CTT and vendor-developed or co-developed documents (e.g., specifications, scope of work, operational manuals, communication plans, retention and recruitment plans, data transfer plans, etc.) as requested to provide operational input (including on-time and high quality)
- Ensure that clinical and data management standards are followed for the study
- Ensure proper collection and validation of data and documentation in a timely manner
- Assure proper overview and communicate to teams (including on-time and high quality) of monitoring activities, data flow, data validation, and when applicable, coordinates the centralized review of procedures
- Perform patient data validation homogeneously and fulfilling required quality standard
- Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant E-rooms and databases as required
- Organize study specific meetings (STM excluded)
- Coordinate and support field-monitoring activities through regular meetings: teleconferences and/or visits; training of monitoring teams, investigator meetings
- Prepare and lead data review meeting, organize and contribute to medical review meetings
- Collect, synthesize and report study information
- Maintain and provide information for monthly study highlights (including enrollment curves and timelines) in a timely manner
- Investigational Product (IP) Management
- Collaborate with the TSOM to validate study IP needs, specifications, packaging, shipment (including resupply) and reconciliation process
- Participate in the development/follow-up of the study budget and selection and management of vendors
- Define needs, tasks and responsibilities of external vendors, review contracts, estimate costs of logistical aspects of the study and ensure tracking payments for operational aspects of the study are done, in collaboration with the Clinical Purchasing department
- Preparation and oversight of study audits/inspections both internal and external
- Provide oversight and preparation for FDA pre-approval inspections (PAI)
- 7 years of Trial Operations Management
- At least 5 years Oncology experience is mandatory
- Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc)
- Bachelor's degree (advanced degree preferred)
- Degree in scientific discipline 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.