The Global Study Manager (GSM) is responsible for the operational planning, management & execution of clinical study and program(s) within Trial Operations.The GSM is the leader of the clinical study team and is empowered to drive the management & delivery of the study team operational objectives, ensuring all trial deliverables are met according to the study timelines, within budget, and having the highest quality standards (GCP / ICH, SOPs / QDs).The GSM leads the preparation of study-related plans and materials, identification of study risks and contingency planning, appropriate escalation of issues, monitors the study planning, manages budget to ensure it is kept within budget, and leads the execution of the study with integrity and suitability for regulatory review.The GSM leads cross-functional study teams, responsible for the coordination of internal/external resources, organization of internal team meetings, and drives and oversees vendors for the flawless execution of studies.Responsible for the management of Clinical and Medical Service Providers, set up & oversight of service providers, and ensures adherence to the scope of work within timelines and budget.The scope of this position requires excellent communication skills (written and oral), a critical-thinking/problem-solving mindset, and strong leadership to manage across functions and drive the operational success of study activities.MAIN RESPONSIBILITIESLeads the Study Team on the Planning and Execution of Clinical Studies:Lead the study team (including representatives from CSUs/affiliates/vendors, Data Management, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics, and other relevant departments) for the operational aspects of the study.
Liaise with the feasibility manager to review and assess feasibility.
Liaise with clinical buyers to prepare the RFP (request for proposal), review the proposal, and participate in the selection of the vendor(s).
Liaise with Operational Excellence Center (OpExC) contributors for vendors' activities and deliverables, directly oversee activities and deliverables for vendors not covered by OpExC to ensure performance expectations are met.
Ensure study progress is aligned with projections: drive and oversee study timelines, track budget, and escalate risks to timelines and budget as needed.
Communicate changes and progress.Ensure proper documentation/availability:Develop following study documents as the author: Monitoring Plan, Study Communication Plan, Study Risk Management Plan, and any study operational material (e.G.
Study newsletters, memo, etc.)
as needed; Co-develop documents with vendors (if OpExC is not involved): specifications of central services, scope of work, operational manual, etc.
in conjunction with the study team.
Review study team-developed documents including ES, protocol, amendments, and WSI (operational sections), eCase Report Form, CRF completion guidelines, Centralized Monitoring Plan, recruitment and retention plan, committee charters, and/or other operational documents as requested to provide operational input (including on-time and high quality).
Ensure study documentation is properly maintained and archived in the Trial Master File (TMF).Organize study-specific meetings:Organize and lead the core and extended study team meetings, including risk management discussions with the cross-functional team throughout the study lifecycle.
Organize and lead meetings/TCs with local team representatives to oversee study progress.
Ensure the training of the monitoring team, participate in investigator meetings, and organize and lead meetings/TCs with vendors (for vendors not managed by OpExC).Participate in the selection and management of vendors:Define needs, tasks, and responsibilities of external vendors, participate in the BID, review contracts, estimate costs of logistical aspects of the study, and ensure tracking payments for operational aspects of the study in collaboration with the Clinical buyers.Develop and manage the study budget:Support the CSO/PL in the preparation of the overall study budget (SPE).
Follow up on the budget during the study, making forecasts, and tracking expenses/accruals, identifying and evaluating complementary needs.
Perform final budget reconciliation with vendors at study end.Prepare and oversee study audits/inspections:Ensure preparation and proper responses to audit/inspection reports for findings associated with GSM; ensure discussions are made with study team members during Study Team meetings regarding important observations to develop and implement immediate action plans at global CSU/sites/vendors level if needed.About youExperience:Experience in Digital for clinical studies and Research & Development.
Experience of working internationally, anticipating and resolving problems.
Managing cross-functional team members to drive operational success.
The GSM ensures alignment across the study team functions to ensure delivery of study milestones and ensures milestones and study goals are aligned with those of the project team and Trial Operations.Key Internal and External Relationships:Other study team members, Project Leaders, CSUs, Regulatory, GPE, UMO, Legal, Procurement, Clinical Research Organizations (CROs) and other clinical study vendors (e.G.
IVRS, Central Laboratories), Academic Research Organizations, External Steering Committee members.Technical and soft skills:Strong working knowledge of digital.Through sharing of experience.May participate in the development of training materials/processes.Assist other GSM or newcomers in their self-development (digital-related expertise and soft skills such as communication, leadership).Act for change: Creatively challenge the status quo to find new ways of working and proactively propose solutions.Collaboration with partners: Ability to effectively interact with scientists and managers within and outside Sanofi, serving as internal consultant on assigned area (e.G.
Subject Matter Expert) and liaise with external organizations on projects.Actively seeks feedback to identify opportunities for improvement and to gain insight into underlying needs.Education:Degree in scientific discipline or equivalent RN preferred.Why choose us?Bring the miracles of science to life alongside a supportive, future-focused team.Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare.Better is out there.
Better medications, better outcomes, better science.
But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
So, let's be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.About UsSanofiWhy SanofiAs an organization, we change the practice of medicine; reinvent the way we work; and enable people to betheir best versions in career and life.
We are constantly moving and growing, making sure our people grow with us.
Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.#J-18808-Ljbffr
