16 ago
|
Syneos - Clinical and Corporate - Prod
|
Milano
16 ago
Syneos - Clinical and Corporate - Prod
Milano
**Description** Global Feasibility Lead. EMEA. Sponsor dedicated. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE** Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong. **Responsibilities**:
**Position Purpose**:
The Global Feasibility Lead will be responsible for partnering with other roles,
to enable the predictable delivery of the client’s portfolio by providing rapid, accurate and robust assessments of program and protocol feasibility, recruitment enrollment assumptions, and site strategy plans. This individual will provide the study team with robust scenario planning to inform and finalize an optimized country, site and enrollment study enrollment plan by leveraging data driven estimates, benchmarking assumptions, competitive intelligence, indication level knowledge, internal and external data sources, and the site predictability engine. This individual drives country and site selection for PTA for the study plan and leads the delivery of sites endorsed for Pre Trial Assessment for the study through the planning of the optimal country and site footprint taking into consideration site segmentation strategies. At the Sr. Manager level, the Global Feasibility Lead provides the study team recommendations on country and site selection, develops ideas to bridge the gap between evidence driven assumptions and 3x3 recruitment goals and has advanced knowledge in the field of country and site strategy and feasibility. **Role Responsibilities**: - The Global Feasibility Lead (GFL) is the single point of contact for the study team in the build of evidence driven study assumptions to provide a country and site strategy that includes a list of proposed countries and sites to be targeted during site feasibility/selection,
enrollment scenarios, and protocol optimization strategies. GFLs will continue to support study team enrollment to assess future changes to that strategy (e.g. plan adjustments or rebaseline) through the completion of participant recruitment
- Provides early feasibility (before core protocol elements are available) by providing initial enrollment timelines, potential country footprint, primary intelligence gathering (benchmark studies, competitive landscape, treatment approvals etc), and key enrollment assumptions to inform initial high level Op Plan assumptions
- Introduces opportunities for protocol optimization by leveraging real world data, investigator insights, patient insights, protocol simulations, and coordinates with relevant functions to incorporate these insights in study assumptions.
- As protocol elements evolve to final protocol and start up stages, the GFL will continue to evolve detail on country footprint, enrollment assumptions, and appropriate site segmentation strategy
- Support the build of the investigator database, collection of information supporting the definition of the ideal site for a study, identification of suitable sites for a study, and coordinate global efforts for site intelligence
- Author and maintain oversight of both Country and Site Feasibility outreach and engagement, lead response reviews with appropriate study team members, and provide strategic input into team decision making
- Analyze results of outreach and evidence to build the recommended country and site strategy
- Provide summary site analytics as the volume of sites is progressed through evaluation stages to Pre Trial Assessment (PTA) to ultimate Site Selection. Analytics include modeling
📌 Global Feasibility Lead. Emea. Sponsor Dedicated (Milano)
🏢 Syneos - Clinical and Corporate - Prod
📍 Milano