Regional Oversight Monitor - Northeast, Southeast, Central and West

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.   

We are hiring (4) regionally based roles. Sites are located in Northeast, South East, Central and West regions. Preference is for candidates to reside within the region.

Responsibilities:

Sponsor Oversight Visits – Site Assessment Visits

Onsite and Remote Oversight Monitoring:

• Perform both onsite and remote Site Assessment Visits as part of sponsor oversight. Assess protocol compliance, data accuracy, GCP compliance, gaps in site practices and gaps in monitoring practices. Other aspects of the clinical trial, site performance and/or monitoring may also be evaluated as needed.

• Provide real-time feedback during site visits on critical aspects such as informed consent process and overall data quality. Provide mentoring and coaching as needed. 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. Prepare comprehensive oversight reports summarizing findings, recommendations and corrective actions from Site Assessment Visits.

Study Operations Oversight Management:

• Report findings and collaborate with Monitoring Oversight team and GCO study teams for issue escalation and identified gaps. Maintain comprehensive records of monitoring oversight activities, including documentation of the selection of sites for the Site Assessment Visits. Assist with trend analysis of issues and gaps identified across all Site Assessment Visits.

• Liaise with CROs and/or cross-functional teams to implement quality control measures and risk management strategies to proactively identify and mitigate potential risks of site/CRO monitor oversight findings

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

Education:

• Bachelor's Degree BA/BS in related discipline required.

Experience Qualifications:

• BA/BS in related discipline required

• 6+ years’ pharmaceutical-industry experience, at least 5 of which is in a clinical operations CRA capacity with significant involvement in on-site monitoring. Preferred

• Experience in mentoring and training sites and/or other CRAs required

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

• Strong knowledge of GCP, ICH and other applicable regulatory requirements required

• Proficiency in EDC, eSource, eMR and eTMF systems preferred

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

• Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment required

• Excellent intrapersonal and 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 40% Some travel expected and potential for this to increase if/when additional sponsor oversight strategy is defined.

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.