Sanofi Group Clinical Trials Operations Manager in Bridgewater, New Jersey
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. Specific scope for Senior GSM: The Senior GSM possesses proven experience successfully managing and executing clinical projects. He/she independently may manage multiple studies, projects or phases of a larger project / higher TA complexity (i.e. accelerated timelines, complex operational study design and/or high number of complex vendors) and effectively builds relationships with internal and external project stakeholders to ensure seamless transition of the project(s) as they progress through development plan. The senior GSM is responsible to bring innovation in operational solutions.
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 (teamwork), 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 (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.
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.
Formal 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.
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.