Job Title: Clinical Trial Operations Manager III
The Clinical Trial Operations Manager (CTOM) is responsible for part of the operational aspects of clinical trial oversight including the delivery of every study on time within budget and scope in compliance with GCP's, SOPs and standards.
The CTOM supports the Senior Lead CTOM and/or Lead CTOM in the scientific conduct of the study and acts with a critical thinking and problem solving mindset.
This role will be involved in the scientific conduct of the study and act under the guidance of the Senior Lead CTOM and/or Lead CTOM to guarantee release of homogeneous high quality data in close collaboration with others Clinical Science Operations (CSO) department representatives (e.g. Medical Operations).
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 company products.
• 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
Education & Qualifications
• Bachelor's Degree plus
• At least 2 years of experience in the pharmaceutical industry or clinical-related discipline (including at least 1 year of clinical research experience).
• Advanced Degree in scientific discipline preferred, equivalent RN
• 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
• Medical, Dental, and Vision Insurance
• 401K Plan with Company Match
• Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.