Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The CRA Oversight Associate Director plays an integral role in the strategic development, oversight, and execution of global monitoring conduct across the DS portfolio. This position will serve two key roles: 1) support subject matter expertise (SME) with the CRO oversight leads and 2) contribute to and plan for future growth of a CRA organization. This is a highly collaborative and dynamic role within a fast paced and results-oriented environment. This role will embody principles of Quality by Design (QbD) as it directly relates to risk-based monitoring (RBM) and Central Monitoring.
Responsibilities
CRA Oversight and SME:
- Develop and implement a monitoring oversight strategy to ensure quality and compliance across the organization with applicable policies and procedures as outlined in study-specific monitoring plans.
- Oversee the development and ensure the execution of monitoring activities that are outlined in the various study/CRO plans across portfolios.
- Ensure CRO CRAs have quality oversight plans in place with detailed escalation pathways.
- Ensure a strategic and manageable site engagement strategy is in place in accordance with the RSEM and local country teams.
- Partner with TMF lead and CRO Oversight leaders to ensure CRAs are updating appropriate systems.
- Ability to analyzes data/metrics/key performance indicators to support vendor/CRO oversight of CRAs in clinical trials.
- Provide direction to Alliance and CRO CRA leadership on major study commitments including resolving any key issues identified.
- Ensure the CRO is overseeing CRA study activities at study and country level and complying with local policies and code of ethics.
- Collaborate on the development of monitoring plan templates including review and annotation of monitoring-related documentation.
- Review or ensure a model is in place for review of monitoring visit reports of direct reports.
- Collaborate, execute, implement, and provide oversight on the agreed RBM strategy and ensure the strategy is in place for every study for CRAs to execute against.
- Identify trends and escalate significant issues and findings in a timely manner.
- Support monitoring process checks linked with CRA activities that require inclusion in the quality plan.
- Lead, participate, or support internal audit and regulatory inspection activities related to site monitoring and sponsor oversight.
- Contribute to the quality improvement of the study processes and other procedures and ensure sites are inspection ready.
- Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders.
- Contribute to SOP updates.
- Strategize Future CRA Organization
- Based on resource decisions and approaches, support the set-up, management, processing, and troubleshooting of FTE or a Functional Service Provider (FSP) to source CRAs. This may include issue escalation or resolution regarding resourcing or program delivery. Partner with each study team and program leads to establish appropriate CRA resourcing, deployment, coordination, training, and prioritization. Manage resource strategies and capacity management in accordance with budgetary requirements and emerging priorities to ensure studies are delivered as planned and critical study timelines are achieved. Ensure equitable and fair workload balance for CRAs. Support successful delivery to plan, with speed and quality.
People Management:
- At the time of hire this role will not have direct reports, but there is a likelihood to develop a team of CRAs. If/when the roles assume direct reports, it will be expected this leader:
- Coach the direct reports on a regular basis, and plan/organize coaching with external providers if needed.
- Ensure capability build, individual development, and performance management.
- Accountable for resource and capacity management within respective portfolio and collaborating with peers to optimize talent in the organization.
- Ensure the GPT GCO reps are functioning at a high and consistent level. Coordinate training and onboarding of new CRAs. Drive a feedback-oriented culture.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications: (from an accredited college or university)
- Bachelor's Degree required.
- Master's Degree preferred.
- Experience Qualifications
- BS in related discipline, or equivalent work experience required.
- 8+ years’ experience in clinical operations CRA capacity required.
- 5+ years’ experience in proven global line management expertise; experience of performance management and development of Manager level staff. required
- Relevant therapeutic experience and proven ability to learn new indications. required
- Proven experience in Project Management leading and implementing improvement initiatives, novel technology or techniques in the context of clinical development. required
- Proven change management experience required.
- Proven strategic and innovative thinking required.
- Functional management experience, managing resourcing and budget planning/oversight required.
- Ability to collaborate and establish a well-connected network with other Early/Late Leaders and Clinical Operations Leadership required.
- Demonstrated ability in influencing others in a matrix environment required.
- Awareness of external competitive environment and operational practices required.
- Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment required.
- Excellent written and verbal communication skills required.
- Willingness to travel both domestic and international required.
- Proven ability to develop successful collaborations with internal and external partners required.
- Maintains high standards, including a commitment to Daiichi Sankyo values, policies and employment principles required.
Travel:
- Ability to travel up to 20%.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
