Site Partnership Manager & Clinical Project Leader
Sanofi
Athens
πριν από 1 μέρα

Site Partnership Manager & Clinical Project Leader

Location : Athens

About the Opportunity

The Site Partnership Manager (SPM) mission is to build strong relationships, enhance level of collaboration, and seek for input and insights from Investigational sites to drive site performance such as increasing the no.

of patients / site, accelerating study start up and reducing overall development milestones through faster patient recruitment.

The SPM is the dedicated point of contact across and in between studies to identify with the right stakeholders eventual obstacles that can limit the site performance and together to look for a solution, to improve study related elements.

The Clinical Project Leader (CPL) is responsible for the set up and progress of a clinical trial / observational study / special program in his own country or in the assigned countries in the South Europe, ensuring compliance with Sanofi Group quality standards and regulations in force, the forecasted timelines, milestones and budget.

Key responsibilities

Site Partnership Manager :

Responsible for establishing new sites as Partner sites aligned with portfolio and country strategy by working with local stakeholders in new site recommendations, evaluation, and selection to be part of the site partnership management program.

Collate information for internal stakeholders, launch, support, and train new sites to the partnership.

Collaborate with Projects Teams for Partner sites early and continuous engagement by :

Reviewing General Portfolio & Upcoming Studies in light of Partner sites objectives that achieve operational efficiencies and milestone acceleration

Discussing with Site Partners any opportunities related to operational efficiencies, patient recruitment activities, new indications, site development

Collaborate with MDAs and Projects Teams, for involving Partner sites and getting robust and meaningful feedback during study concept phase and Operational feasibility

Collaborate with MDAs and Project Teams for patient recruitment and retention (PRR) strategies

Discuss, challenge, and agree upon patient recruitment target with partner sites and study team, in alignment with Site partnership model expectations

Ensure mutual (site and Sanofi) prioritization at study start up

Track overall Partner site activity and performance using the appropriate tools and propose action plan recommendation accordingly when risks to recruitment plan identified.

If data quality issues identified, SPM will partner closely with the local monitoring team to assure the site delivers quality data per expectations of study timelines

Clinical Project Leader

Is accountable for set-up and progress of the study according to the company standards and regulation in force and ensures that committed targets and timelines are met at all steps and until study completion

Collaborates with the local Medical Advisor to identify potential investigators

Organizes the set up and implementation of the assigned Clinical Projects ensuring high quality management of the study

Ensures timely and appropriate execution of the assigned clinical studies and follows-up their progress of implementation

Leads the monitoring team in the country

Ensures liaison with other local team members and with the study team at global study management level

Ensures the selection, management and oversight of the Contract Research Organization, in case of subcontracted studies

About You

To excel in this role, you need to be skilled in :

Essential requirements :

Educated to University degree level in scientific or health science. A post graduate qualification is highly desirable

At least 5 years of experience as Clinical Research Associate

Additional experience as a Project Leader or equivalent role is highly desirable

Knowledge of GCP / ICH phase I-IV clinical trials and observational studies

Strong Clinical Project Management skills needed to effectively manage large number of trials in different therapeutic areas and in different countries

Strong motivation to high performance

Knowledge of the current trends in clinical trials risk-based approach and digital technology

Deep knowledge of quality issues management and FDA / EMA requirements for inspection readiness

Strong leadership and excellent interpersonal and communication skills including a good customer focus mentality

High organizational, analytical and planning abilities, proactivity and ability to anticipate and resolve conflicts / issues, reactivity to emergent needs, ability to prioritize, time management

Good IT skills, are essential, for planning, tracking, communicating and reporting

Fluency in Greek & English (verbal and written), any additional language will be a plus

Driving license

Inspire your Journey :

What Sanofi can offer you :

An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team

An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g.

company pension plans, health management)

An individual and well-structured introduction and training when you onboard

You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully

As a globally successful and constantly growing company, Sanofi provides international career paths as well

We are proud to have been awarded Global Top Employer 2021.

LI-EUR

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