Director, Site Management

il y a 6 jours


SaintOuenl'Aumône, France Pfizer, S.A. de C.V Temps plein

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life‑changing medicines to the world.Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.ResponsibilitiesThe Director of Site Management and Monitoring (DSMM), in partnership with the Director of Clinical Site Operations (DCSO), is accountable for ensuring appropriate site management and monitoring resources (e.g., Site Care Partner (SCP), Clinical Research Associate (CRA), Site Monitor) are in place to deliver on both country and site‑level end‑to‑end study start‑up, management and monitoring activities in line with study milestones in the designated countries/clusters/regions, as well as providing line management, overseeing the job function of the roles.The DSMM supports the DCSO, who is accountable to ensure overall site operations and site management and monitoring activities within designated countries/clusters/regions and supervises requirements for sites to ensure participant safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Pfizer standards.The DSMM partners cross‑functionally with others in Study Start‑Up (Start‑Up Project Management (SUPM), Site Activation Partner (SAP), Clinical Trial Assistant (CTA), Investigator Contracts Lead (ICL)), Optimization, Analytics, and Recruitment Solutions (OARS), Patient Recruitment and Study Management to provide input to country and site selection and collaborate with country regulatory/regional Clinical Trial Regulatory Operations (CTRO) to facilitate Clinical Trial Application/IRB/EC approval for allocated studies in their designated countries/clusters/regions, when applicable. The role also executes investigator site/recruitment strategies and site‑level end‑to‑end study start‑up, management and monitoring activities.The DSMM will lead, contribute to, and implement strategic initiatives as a representative of GSSO Leadership. They will also lead initiatives that shape the clinical development environment within designated countries/clusters/regions to facilitate Pfizer’s clinical development goals and scientific leadership. For example, this role actively manages risks and identifies opportunities for clinical trial conduct through engagement with local clinical development leaders and/or regulatory authorities, actively participates in local industry forums, builds portfolio‑aligned, investigational sites/site organization relationships to shape performance of ethical clinical research, as needed (e.g., Decentralized Clinical Trial (DCT) readiness, virtual monitoring, and drive the cycle times reduction).The DSMM may be aligned with assets within Therapeutic Areas to serve as a strategic point of contact for items such as planning, quality events, inspections. The DSMM may be aligned to a centralized service (e.g., informed consent processing) to serve as a strategic point of contact / lead for items such as planning and delivery.The DSMM provides insights on local/regional trends to facilitate the conduct of clinical trials and, where appropriate, is responsible for developing analyses and offering options for mitigation (both at the country/cluster and site level) on the trial’s conduct.Qualifications / SkillsEducationMust be fluent in English. Local language capabilities are an advantage in this role.In general, candidates for this job would hold the following levels of education/ experience: BS/BSc/MS/MSc or equivalent and extensive clinical research experience; PhD/MD or equivalent and extensive clinical research experience.ExperienceExtensive knowledge (minimum 10 years) of clinical trial methodologies with proven ability to deliver high quality clinical trial conduct obtained while working with a multi‑national pharmaceutical company and/or clinical research organization.SkillsDemonstrated People management experience.Ability to lead and manage diverse teams.Demonstrated ability to exhibit adaptive risk management and continuous learning capabilities.Ability to lead and influence a matrix environment, capable of driving initiatives across GSSO.Demonstrated understanding of People Experience (PX) procedure and policies at global and local level.Demonstrated ability to engage with senior stakeholders internally and externally to the organization.Ability to work effectively with line support functions including finance, PX across the region.Ability to both manage the resources required to deliver on organizational commitments and perform specific tasks of the roles managed.Ability to effectively coach and train direct reports including management of escalated issues from sites / investigators, and development of core competencies.Availability to travel within the region and/or globally as required.Agility to adapt to VUCA (Volatility, uncertainty, complexity and ambiguity)/evolving environment.Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Handicap & InclusionOur mission is to liberate the potential of our employees and we are proud to be an inclusive employer for people with disabilities, ensuring equal employment opportunity for all candidates. We encourage you to give your best, knowing we will make reasonable adjustments to support your application and future career. Your experience with Pfizer starts here.Égalité des chances & EmploiNous croyons que des équipes diversifiées et inclusives sont essentielles à la réussite d’une entreprise. En tant qu’employeur, Pfizer s’engage à valoriser la diversité et l’inclusion sous toutes ses formes. Cette diversité se reflète également à travers les patients et les communautés que nous servons. Ensemble, continuons à bâtir une culture qui encourage, soutient et responsabilise nos employés.Breakthroughs that change patients’ livesResearch confirms what intuition tells us: that purpose‑driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro‑innovation/pro‑patient policies.Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.Our ValuesTo fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.Benefits at PfizerPfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.Our Competitive Benefits Programs help our colleagues by:Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing . Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced‑cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12‑week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country‑specific programs.And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on‑site health and/or fitness centers , movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more. #J-18808-Ljbffr



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