Associate Director Study Management

at  Astellas

Algemene informatie
Vacatureadvertentie
Associate Director Study Management
Locatie
België
Functie/Business Area
Data & Analytics
Afdeling
Global Department
Werkcategorie
Arbeidsovereenkomst voor onbepaalde tijd
Functiebeschrijving
Associate Director Study Management
About Astellas
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team, or division.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
About this role
As the Associate Director Study Management, you will be responsible for the strategic operational planning, oversight, and execution of Medical Affairs data generation activities, including Astellas Sponsored Research, particularly non-interventional studies in addition to ISRs and Collaborative Research studies.
Under the scope of the role, you will manage budgets, timelines and resources and interact with study teams, study sites and vendors for assigned clinical studies.
Additionally, as part of a continuous improvement ethos you will participate in best-in-class initiatives to improve study execution standards and processes.

ESSENTIAL KNOWLEDGE & EXPERIENCE:

Strong clinical study management skills (including project and financial management) with good knowledge of global drug development, product lifecycle management and clinical study design.
Evidence of solid leadership, negotiation, and management skills with a demonstrable understanding of late phase clinical development. Regional or global experience working with groups across multiple countries/cultural backgrounds.
Experience of CRO/vendor management and related audits and inspections
Strong organizational skills and the ability to prioritize with the ability to navigate change and positively influence others.
Fluent in written & verbal English and local language.

EDUCATION/QUALIFICATIONS:

Bachelors in sciences or equivalent science/ health-related field experience

Direct key initiatives and studies to support Clinical Operations including budgeting and planning, synopsis/protocol coordination, vendor selection and oversight, alignment of timelines and plans. Evaluate clinical trial risks; prepare and execute contingency plans for operational risk including patient recruitment, regulatory environment, and data quality.
Lead feasibility assessment and selection of countries and sites for study conduct, managing cross-functional study teams/vendors.
Create and monitor reports on key performance metrics and status of data generation activities aligned with Core Medical Plans and contribute to the strategic implementation of Evidence Generations Plans
Lead development of study plans and ensure operational excellence of protocols. Oversee clinical aspects of timely data cleaning, data analysis and the availability of top line results. Provide oversight and direction to study team members for study deliverables.
Lead initiatives to introduce best practices, ensuring adoption and execution of GCP/ICH, GPP and other applicable regulations/guidance governing data generation activities in the department.