Clinical Trial Operations Manager III - OQSIE
Cambridge, MA
About the Job
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 the 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 Sanofi 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 the operational plan(s) upon endorsement by the study team
Ensure proper documentation availability
Ensure proper collection and validation of data and documentation in 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
Skills:
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 the 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 changed 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
Education:
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 the scientific discipline preferred, equivalent RN
3 years of experience in the 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
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 the 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 Sanofi 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 the operational plan(s) upon endorsement by the study team
Ensure proper documentation availability
Ensure proper collection and validation of data and documentation in 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
Skills:
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 the 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 changed 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
Education:
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 the scientific discipline preferred, equivalent RN
3 years of experience in the 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
Source : OQSIE
