Clinical Study Manager, Clinical Operations

Job Description

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 15,000 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 incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.

A key focus will be the oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and objectives set forth by the Study team.

The Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy.

Responsibilities:

Study Planning and Execution:

• Develop project cross-functional, integrated study plan to study start up (in-house) and validate and manage to the overall study plan provided by the CRO. Participate in site selection and site qualification with (study team and CRO).
• Contribute to operational delivery aspects of the protocol and take a document review & coordination role for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.
• Take responsibility to ensure meeting logistics, agenda and minutes of the clinical study team are in accordance with DS standards. Act as the project manager of the clinical study team to liaise and coordinate with internal stakeholders to ensure cross functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee the CRO and provide timely input to ensure that the CRO-generated documents are created in a timely manner (communication plan, site monitoring plan, etc) ahead of study start. Oversee CRO study start-up activities and coordinate with functional group to ensure that essential site documents are collected, and sites are initiated per plan. Coordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings and investigator meetings and training.
• Note that vendor management is not limited to the CRO, but includes ancillary vendors (e.g. translations, trial insurance, and central laboratory).
• Work closely and oversee CRO activities for study execution with CRO on a task / operational level per the project plan. Oversee CRF completion and monitoring; Triage, resolve or escalate study issues to the supervisor.
• Oversee CRO study close-out. Liaise with internal Functions to ensure drug destruction process is implemented. Liaise with CRO to support database lock and review of TLG before and after database lock.
• Ensure DS internal tracking systems are updated (e.g. Global Project Management System, GPMS).

CRO and Quality Oversight:

• Responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at a task level. Specifically track short-term operational study timelines and monitor operational performance metrics throughout the study; Identify issues and propose solutions. Proactively assess potential risks to the study and propose mitigation plans.
• Monitor study budget against progress and bring deviations to the supervisor. Review and approve Vendor invoices, including investigator grants and pass-through costs.
• Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures. Contribute toward the creation of the Quality Oversight Plan (QOP) and take a key role in ensuring study team adherence to the QOP. Specifically conduct quality oversight monitoring visits as outlined in QOP. Additional responsibilities include review and documentation of CRO-generated reports such as trip reports, protocol deviation reports, and analysis of site metric reports. Be able to identify areas of concern and either resolve or bring to the attention of the Delivery Lead. Coordinate and liaise with Daiichi Sankyo QA on audit activities.
• Provide oversight of the transmittal of trial and site level documents to the Daiichi Sankyo Document Control Center (DCC) in support of the Trial master File (TMF). Reconcile the CRO-generated TMF document trackers with the document archive. Identify and resolve issues with the reconciliation.

Knowledge Management:

• Support Department in codifying existing knowledge and best practices; Prepare training in area of expertise. Make recommendations for areas of improvement and innovation (study, or departmental level). Educate the team on adherence to SOPs, GCPs and on best application of operational tools. Work with supervisor to provide input into individual career development plan.

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 in the Sciences preferred.
• Associate degree or with a nursing diploma with substantial experience preferred.

Experience Qualifications:

• 4 or More Years relevant experience is required with a BS preferred.
• 1 or More Years with a MS./MPH preferred.
• 1 or More Years with PharmD/PhD preferred.
• Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant preferred.

Travel:

• Ability to 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.