Sanofi Group Clinical Trial Manager in Cambridge, Massachusetts
Clinical Operations Experience Managing Study Activities:
Responsible for the conduct of studies ensuring adherence to FDA regulations, ICH GCP guidelines and SOPs/QDs.
Manage all components of clinical trials from study outline / protocol through CSR completion. Includes reviewing and implementing protocols, site selection, collaborate in the design of eCRF, review of data management plans, developing monitoring plans and training site staff, internal staff and monitors on protocol specific procedures.
Maintain study timelines during the planning, initiation, ongoing/active and study completion stages of clinical trials.
Experience or awareness in site selection (qualifications), SIVs, Monitoring Visits and Close Out Procedures.
Manage preparation and overseeing budgets successfully.
Lead review of supplier SOWs and accuracy of clinical outsourcing vendor agreements including CRO, IRT, Central lab, eCOA, ECG and electronic data capture as well as manage vendors with respect to contracted scope of work and budget.
Serve as liaison between clinical operations and other functional areas.
Demonstrate a commitment to cultivate innovation, drive operational excellence with activities on time, highest quality and within budget.
Demonstrated ability to act as Leader of the Study Team and being able to efficiently work with other GSMs in the same study.
Ability to collaborate effectively with cross-functional team members and external partners using collaborative negotiation skills.
Experience in managing and leading international meetings (e.g. Study Teams).
Ability to anticipate potential issues, proactively identify ways to resolve/ mitigate, timely escalate issues with appropriate action plans.
Ability to lead transversal projects.
Capability to challenge decisions/status-quo/requests using risk management approach (e.g. unrealistic timelines, unplanned database snapshot.).
Cross-functional leadership fostering team spirit and team motivation (team work), e.g. study team or transversal project team.
Display stakeholder management skills (e.g. ability to manage expectations).
Oversight & Coordination
Solid Project Management background.
Solid experience of oversight on activities covering all study periods from start-up to study report.
Solid organizational skills: results and quality oriented with the ability to multi-task, skill in establishing priorities and meeting deadlines.
Ability to develop and maintain an optimized study planning with other functions (including identification of critical path).
Ability to coordinate multiples interfaces: (e.g.) studies including several vendors.
Ability to work autonomously, to efficiently and effectively provide status reports.
Ability to appropriately delegate responsibilities (e.g., Internally - when several GSM involved on a study/ Externally - in case of outsourced activities).
Ability to identify and implement synergies.
Takes responsibility for decisions and accepts accountability for results.
Ability to prioritize his/her own activities and to drive the team in this exercise.
Excellent written and verbal communication skills.
Strong negotiation skills.
Strong English skills (verbal and written if English is the second language) i.e., ability to exchange fluently (incl. 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.
Encourage collaboration and communication within and beyond the team, contribute to building a positive team spirit.
Decision making & problem solving
Able to identify and anticipate study risks.
Ability to synthetize, propose scenarios or action plans for decision making.
Able to solve problems and make decisions when needed.
Create buy-in/ support from stakeholders.
Collaboration with partners:
Ability to work cross functionally, ability to be flexible and adapt effectively to a variety of individuals.
Experience in the management of vendors for outsourced activities.
Ability to work in an international environment with internal and/or external partners (e.g vendors, database designers, programmers).
Respond constructively to requests (i.e. either accept or challenge the request, why, when, who & what).
Act for change
Ability to learn from experience and able to deal well with the changed circumstances in the environment (be open to new ideas and changes in order to be successful).
Readily adapt to new environment, jobs, technologies and processes (e.g. new CTMS, tools).
Ability to deal with frequent changes, delays or unexpected events.
Through sharing of experience.
May participate in the development of training materials/ processes.
Knowledge of international standards (e.g. GCP, CDISC, etc.).
Knowledge of company tools, processes and SOPs.
Strong working knowledge of Microsoft Office.
Additional skills required from Senior GSM:
Act for change : Creatively challenge the status quo to find new ways of working and proactively propose solutions.
People development : Assist (associate) GSMs/CPA/TMA and/or new comers in their self-development (project related expertise and soft skills such as communication, leadership).
Collaboration with partners :
Ability to effectively interact with scientists and managers within and outside CSO SCP, 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 And Experience Required:
- Bachelor's degree (advanced degree preferred) plus a min of 5 years of experience in managing clinical trials.
Knowledge and Skills Desirable but Not Essential:
Degree in scientific discipline Or equivalent RN preferred.
PMP certification (optional).
Experience of working internationally.
Experience of anticipating and resolving problems.
Principal Duties and 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. Collect, synthesize and report study information
- Maintain and provide information for monthly study reports (including enrollment curves, timelines, analysis of the study status and identification of potential risks).
5. Investigational Medicinal Product (IMP) Management.
- Collaborate with the Clinical Supplies Platform to validate IMP needs, shipment (including resupply) and reconciliation process.
6. 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.
7. 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.
8. Preparation and oversight of 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 and regard important observations to develop and implement immediate action plan at global CSU/sites/vendors level if needed.
9. Provide oversight and preparation for FDA pre-approval inspections (PAI)
- Upon request, prepare and assist in PAI preparation plan with the PAI project team. Utilize designated tools developed to oversee quality (e.g. CTMS reports, PAI Tools kit) for an Inspection-readiness approach and to prepare for CSU, Study Teams & DRS meetings to optimize monitoring efficiency & quality.
Complexity and Problem Solving:
- 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.
Decision Making Authority:
The GSM is responsible for the operational plan(s) upon endorsement by the study team.
The GSM should consult with the CSO-PL to ensure study decisions are aligned on program timelines, strategy and budget. The GSM should keep the TO-TL informed about operational issues that could affect study/program costs, speed or quality
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.