global study manager

Global study manager

• Location: Barcelona
• Job type: Permanent, Full time

About the job

The Global Study Manager (GSM) is responsible for the operational planning, management & execution of clinical study and program(s) w/in Trial Operations.

The GSM is the leader of the clinical study team and 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 suitable for regulatory review.

The GSM leads cross-functional study teams: responsible for the coordination of internal/ external resources, organization of internal team meetings, s/he drives and oversees vendors for the flawless execution of studies.

Responsible for management of Clinical and Medical Service Providers, set up & oversight of service providers and ensure adherence to scope of work within timelines and budget.

The scope of this position requires an excellent communication skills (written and oral), a critical-thinking/ problem solving mindset and string leadership to manage across functions and to drive the operational success of study activities .

MAIN RESPONSIBILITIES

1. Leads 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, 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. Liaise with lead Study Data Manager (SDM) for data management activities and deliverables. Liaise with each study team members (Stat, CSD, SDM, RTMs… ) to consider any input/requirements that could impact the operational conduct of the study. Ensure study progress is aligned with the projections: drive and oversee study timelines, track budget, escalate risk to timelines and budget as needed. Communicate changes and progress.

2. 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)

3. Organize study specific meetings Organize and lead the core and extended study team meetings, including risk management discussions with 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 Organize and lead meetings/TCs with vendors (for vendors not managed by OpExC) Contribute to data cleaning, data review meetings

4. Participate in selection and management of vendors, development/follow-up of the associated budget 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

5. Develop and manage the study budget Support the CSO/PL in the preparation of the overall study budget (SPE). Follow-up the budget during the study, making forecasts and following expenses/ accruals, identify and evaluate complementary needs. Perform final budget reconciliation with vendors at study end.

6. Prepare and oversee study audits/inspections both internal and external Ensure preparation and proper responses to audit/inspection reports for finding associated to GSM, ensure discussions are made with study team members, during Study Team meetings as regard important observations to develop and implement immediate action plan at global CSU/sites/vendors level if needed

About you

Experience

Experience in Digital for clinical studies and Research & Development

Experience of working internationally, of anticipating and resolving problems

Major Challenges/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.

Others 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  

- People development

• Through sharing of experience
• May participate in the development of training materials/ processes
• Assist other GSM or new comers 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 to underlying needs

Education:

Bachelor's degree

Degree in scientific discipline Or equivalent RN preferred

Language: Fluent in English

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,

Pursue progress, discover extraordinary

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.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!