Clinical Operations Manager, Global Medical Affairs

This is what you will do

Within the Global Medical Affairs and reporting to the Vice-President, GMA Top 5 Strategic Partner, Evidence Generation & Chief Scientific Officer, the Clinical Operations Manager leads the operational activities and oversees execution of GMA-generated data, as part of the Evidence Generation Plans, with a focus on respiratory products.

You will be responsible for

• Leading and overseeing the GMA execution of customer insight-driven studies (all areas) in support to patient centric efforts
• Collaborating closely with the GMA therapeutic areas and patient-centered outcomes teams, leading the execution of the studies defined in the Evidence Generation Plans and providing operational expertise and input for assigned programs
• Challenging study team to ensure operational feasibility, inclusive of patient, site burden and budget
• Providing guidance and act as GMA reference point for providers/CROs, in close cooperation with GMA therapeutic areas
• Managing and overseeing the contracting stage and work with Chiesi Global Legal Department throughout the planning and contract execution phase
• Overseeing study budget planning and management. Validating and monitoring timelines
• Working with GMA therapeutic areas in liaising with Chiesi Global Clinical Development/Clin Ops, to oversee programs that are led by GMA but operationally executed by GCD Global Clinical Development (including alignment during strategic checkpoints and supervision of budget and timelines)
• Coordinating GMA operational activities for Chiesi sponsored multi-country studies involving the affiliates, directly liaising with local operations, and assuring application of company’s high-quality standards
• Supporting GMA therapeutic areas in the involvement of local medical affairs in study evaluation, identification of clinical sites and field based (MSLs) contribution to phase 3 and 4 clinical trials
• Leading initiatives to progress modern and pragmatic data generation programs, leveraging patient insights and digital methodologies, e.g., decentralized, AI-based/Machine Learning approaches
• Scouting new sources of data for evidence generation from different settings, going beyond the traditional clinical trials (e.g., public information, medical enquiries, insurance data, social media platforms, market research)

You will need to have

• Bachelor’s Degree (Life Sciences)
• At least 4 years of pharma industry experience
• Fluent English
• Experience in managing Clinical Trials, including interventional and non-interventional studies; coordination and tracking methodologies for data generation, including using databases; knowledge of global regulatory and compliance requirements for clinical research, e.g., US CFR, EU CTD, and ICH GCP.
• Knowledge of budget, contract negotiations and project management
• Self-directed, motivated and results-driven with ability to manage multiple priorities and projects Customer and quality focused with high sense of accountability and urgency to prioritize deliverables. Able to proactively identify issues and risks, analyze root cause, propose solutions, and escalate to management
• Detail oriented and highly organized with excellent planning and time management skills
• Collaborative with internal and external stakeholders to ensure all expectations are clearly defined and achieved
• Enthusiastic, energetic, with a positive, flexible, and approachable attitude, professional and team-oriented

Location

The role can be based in one of Chiesi affiliates in Europe with availability for international travel.