At Astellas, we believe that nurturing exceptional relationships with our employees delivers exceptional business results.
Everyone at Astellas has a responsibility for creating a brighter future for patients around the world. From the first moment, Astellas will inspire you to put this ethos into practice – with a positive, agile company culture and with well-defined ethical principles, values and systems.
Everything we do is led by our company values of integrity, being patient centric, taking ownership, delivering results and communicating openly. These values are essential to Astellas’ relationship with its employees and now is an exciting time to join us as we continue to evolve as a cutting-edge, value driven life sciences innovator.
The Associate Director Study Management will mainly be asked to manage the more complex studies; i.e. Interventional Studies & observational studies, primary use of data.
- Responsible for strategic operational planning, oversight and execution of Medical Affairs data generation activities, including Astellas Sponsored Research (interventional, non-interventional and HEOR studies), Investigator Sponsored Research (ISR) and Collaborative Research (CR) studies.
- Plan, initiate and execute assigned studies with operational excellence:
- Accountable for effective management of budgets, timelines and resources for assigned clinical studies, and implementation of appropriate standards and processes to ensure clinical study quality
- Responsible for effective training and management of interactions with study team, study sites and vendors for assigned clinical studies
- Participate in best-in-class initiatives to improve study execution standards and processes and to ensure quality of study deliverables
- The scope of this position is post approval data generation research studies including Phase IIIb/IV. This position may oversee management of multiple studies.
What you will do includes:
Evidence Generation Strategy
- 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.
- Create and monitor reports on key performance metrics and status of data generation activities aligned with Core Medical Plans.
- Evaluate clinical trial risks; prepare and execute contingency plans for operational risk including patient recruitment, regulatory environment and data quality.
- Provide direction and coaching to other study managers for assigned studies.
- Contributes of the strategic implementation of the Evidence Generations Plan(s).
- Performs strategic analysis of project status and issues, ensuring robust risk mitigation strategies are in place, and communicates to appropriate stakeholders. Anticipates complex obstacles and implements solutions or oversees implementation of solutions by vendor.
Evidence Generation Execution
- Lead feasibility assessment and selection of countries and sites for study conduct.
- Manage and lead cross-functional study teams, including vendors.
- Responsible for financial oversight of the program(s), requiring a strong financial acumen; proactively partners cross-functionally for updates to timelines and budgets.
- Development of RFPs, selection of CROs/vendors.
- Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to MA leadership and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
- Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.
- Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data.
- Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.
- Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members.
- Provide oversight and direction to study team members for study deliverables.
- May be assigned to represent region on relevant global study operations forums, committees or taskforce.
- Leads 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.
- Lead or participate in process improvement and quality-related initiatives associated with study execution and deliverables; participate in establishment of best-in-class processes and standards for study conduct.
What you will need:
- Master’ Degree in Pharmacist, Biomedical or Nursing.
- 8-10 years of relevant experiences.
- Experience in managing multiple therapeutic area.
- Experience in HEOR studies, Investigator Sponsored Research (ISR) and Collaborative Research (CR) studies.
- Meticulous with an eye for details.
- Excellent communication skills.
- Attention To Detail
- Biomedical Engineering
- Business Process Improvement
- Clinical Works
- Commercial Awareness