Manager, CRA Monitoring Oversight and Excellence

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.   

Job Summary:

The Manager of CRA Monitoring Oversight and Excellence is responsible for the support of the strategic development, oversight, and execution of global monitoring conduct across the DS portfolio. This position will serve to support the project plan of CRA Monitoring Oversight and Excellence and the CSOP as it relates to monitoring and CRO/vendor oversight. 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 Monitoring Oversight Management:

• Support monitoring oversight strategy to ensure quality and compliance across the organization with applicable policies and procedures, and the development and execution of monitoring activities that are outlined in the various study/CRO plans across the portfolio.

• Ensure study-specific monitoring plans meet the above standards.

• Review quality oversight plans that CRO CRAs have in place to ensure detailed escalation pathways are present.

• Support monitoring process checks linked with CRA activities that require inclusion in the quality plan.

• Responsible for monitoring the following CRA central oversight activities: Determine CROs compliance with monitoring plan for on-site and remote site visits (expectations of staff contact, ISF review, IP review, SDV/SDR, etc.)

• Establish and lead the Sponsor Oversight Visit process. Provide oversight of the DS Trip Report Review process.

• Responsible for ensuring oversight of Central Monitoring activities according to the Clinical Monitoring Plan inclusive of trend identification, impact assessments and creation of action plans/mitigations which are brought to resolution.

• Participate in/facilitate constructive change by identifying areas of improvement to support overall CRO CRA monitoring oversight and share findings with appropriate stakeholders/team leadership.

• Collaborate on the development of monitoring plan templates including review and annotation of monitoring-related documentation.

• Contribute to and support the oversight of the agreed RBQM strategy and ensure the strategy is in place for every study for CRAs to execute against.

Metrics and Analytics:

• Ability to analyze data/metrics/key performance indicators to support vendor/CRO oversight of CRAs in clinical trials.

• Contribute to KPI/metric development in collaboration with Strategic Vendor Oversight role and AD of CRA Monitoring Oversight and Excellence role

• Support the model in place for DS Trip Report Review via reviewing analytics and metrics of MVR and CRO dashboards

• Identify trends and escalate significant issues and findings in a timely manner.

Study Operations Oversight Management:

• Contribute to the oversight of Qualification and Training of CRO staff especially as it relates to CRAs. Assist with creation and/or review of CRO and site training material as stated in the CSOP

• Support and/or lead mitigation of CRO/vendor oversight findings.

Additional Collaboration Opportunities:

• Support strategic and manageable site engagement in accordance with the RSEM and local country teams.

• Collaborate with TMF lead and CRO Oversight leaders to ensure CRAs are updating appropriate systems.

• Collaborate with Alliance and CRO CRA leadership on major study commitments including resolving any key issues identified.

• Participate in 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.

• Contribute to SOP updates.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education:

• Bachelor's Degree in related discipline, or equivalent work experience required

Experience:

• 4 or More Years 5+ years' pharmaceutical-industry experience, at least 3 of which is in a clinical operations CRA capacity. required

• Relevant therapeutic experience and proven ability to learn new indications. required

• Project Management experience and skill sets Macro Level oversight to gather input from external and internal stakeholders to make day to day decisions required

• Ability to collaborate with a well-connected network with other Early/Late Leaders and Clinical Operations Leadership 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:

• Travel up to 10% In-house office position that may require occasional travel (global).

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.