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Clinical Trial Operations Manager III
Ref No.: 18-10624
Location: Bridgewater, New Jersey
This role will also support the Senior Lead CTOM and/or Lead CTOM for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning ensuring that all activities are managed to the highest quality to strive for safety and effectiveness of Sanofi products. Trial Mgmt, pre-approval inspectation readiness experience required.
Responsibilities
Provide oversight on study activities to ensure progress according to study timelines
Support the Senior Lead CTOM and/or Lead CTOM in taking study logistic decisions and implementing operational plan(s) upon endorsement by the study team
Ensure proper documentation availability
Ensure proper collection and validation of data and documentation on a timely manner
Organize and lead study meetings
Collect, synthesize and report study information
Collaborate with the Clinical Supplies Platform to validate Investigational Medicine Product (IMP) needs, specifications, packaging, shipment (including resupply) and reconciliation process
Participate in selection and management of vendors, development/follow-up of the associated budget
Preparation and oversight of study audits/inspections both internal and external
Provide oversight and preparation for FDA pre-approval inspections (PAI)
Participate in the training of new CTOMs on therapeutic area and general responsibilities within their function

Preferred Experience
3 years of experience in pharmaceutical industry, 2+ years clinical research experience and 1+ years of prior management and/or supervisory experience in coordinating vendors, budget management or country management
Ability to manage and lead international meetings (e.g. Study Teams)
Ability to work cross-functionally fostering team spirit and team motivation (e.g. study team or transversal project team)
Good Project coordination skills
Good organizational skills including attention to details
Ability to develop and maintain an optimized study planning with other functions (including identification of critical path)
Ability to handle multiple tasks, prioritize his/ her activities
Ability to coordinate multiple interfaces, both internally and externally
Ability to anticipate, timely escalate issues and to define appropriate action plans
Ability to work autonomously to efficiently and effectively provide status reports
Participation to routinely data management activities and oversight, data review and analysis (clinical operational) to propose actions and a remediation plan
Good written and verbal communication skills
Good negotiation skills
Strong English skills (i.e., ability to exchange fluently including negotiation, lead international meetings, write meeting minutes/ emails/ study documents / internal & external communication)
Alert on purpose, communicate on issues with proposed action plans
Ability to adapt his/ her communication, address the right topics and adapt content/level of details to the right recipients, select topics to be addressed internally first
Experience in the management of vendors for outsourced activities is preferred
Ability to work in an international environment with internal and/or external partners (e.g vendors, database designers, programmers)
Ability to learn from experience and develop a change mindset
May assist trainees/Clinical Project Assistant/Trial Management Assistant and/or new comers in their self-development (project-related activities)
Knowledge of International Standards (e.g. GCP, CDISC, ....), company tools, processes and SOPs,
Good working knowledge of Microsoft Office