Evidence Generation Project Manager

Job description

Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health . We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities. But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets. Purpose of the Job As part of the Evidence Generation team within Global Medical Affairs, you provide operational excellence support to the Evidence Generation team. You take ownership of the operational management of evidence generation meetings and projects to ensure they — from initiation to planning, execution, monitoring and controlling — are delivered in compliance with the stablished governance within the scope of Evidence Generation Governance at Alfasigma. You work with the Strategic Planning & Operations, medical leads at global and local level, global Publication leads, commercial teams, finance, applicable vendors, external stakeholders (such as Primary Investigators) and relevant R&D functions. Your role Governance coordination – Coordinate the Evidence Generation meetings and process, ensuring follow-up on new and ongoing projects (ISR, SCR, PHA and Phase IV NI studies). Meetings in scope include and are not restricted to monthly Evidence Generation Committee (EVGEC), quarterly Data Alignment meeting (DAM), bi-weekly team meetings, and eventual operational support to ad boards and evidence generation workshops, including minutes and presentations. Evidence generation contract ownership – Act as contract owner for evidence generation contracts within the GPMS Rx Contract Process: initiate Contract Request Forms in CLM, brief Procurement, coordinate internal review (privacy, compliance, pharmacovigilance where applicable) and steer contracts through to execution and PO issuance. Stakeholder management – Manage external sponsored evidence generation projects (ISRs and Collaborations) within IEnvision portal — maintaining day-to day oversight (incl. budget), timelines, metrics and quality — through regular contact with primary investigators and country representative and escalating performance issues through the agreed framework. Integrated evidence plans & trackers – coordinate timelines and roll out of Integrated Evidence Generation Plans for existing and new strategic products, and drive maintenance of the project tracker for each therapeutic area (timelines, milestones, changes). Integrated Evidence Plans are owned developed and maintained by the relevant Evidence Generation Leads. Maintain evidence generation and EAP budget tracker oversight through monthly input for the accountable evidence generation lead or budget owner. Stakeholder communication – Ensure appropriate communication of evidence generation projects status; develop and run project plan newsletters and distribute to relevant stakeholders within the organization. Risk & continuous improvement – Identify and manage operational risks and issues with the team, implement contingency planning, drive lessons-learnt sessions, and develop, maintain and optimise project plan templates, processes, charters, SOPs, dashboards and systems (e.g. the Investigator Sponsored Studies portal) in line with Alfasigma business processes. Cross-team operational support – Provide operational or coordination support to cross functional workstreams within GMA teams where needs arise (e.g. governance, special initiatives, automation, new affiliate onboarding), as prioritised with the Global Head SP&O. Who you are At least 5 years of experience in pharmaceutical or biotech project management. Previous experience in medical affairs or clinical research preferred. Experience managing external vendors or CROs preferred. Familiarity with contract lifecycle processes and working with Legal and Procurement preferred. Bachelor’s degree in life sciences, medicine, pharmacy or a related field. Advanced degree (Master’s or PhD) is a plus. Excellent analytical, planning and organising skills. Out-of-the-box thinking and openness to digital ways of working (project tracking, dashboards, automation of recurring reporting). Excellent stakeholder management skills, with a proven track record of consensus building and conflict management in challenging situations. Contributes to a sound project environment allowing the team to focus on project delivery. Strong written and verbal communication skills as well as excellent MS Office skills. Fluent in English, both in speaking and in writing — knowledge of Italian is a plus. Why Join Alfasigma: At Alfasigma, we foster a culture where the courage to innovate is key to our success. We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress. Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.