Daiichi Sankyo Inc. Senior Clinical Study Manager in Basking Ridge, New Jersey
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The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, 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.
The Senior Clinical Study Manager will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally important. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the U.S. and abroad, governmental, academic, community and industry organizations.
Study Management & Leadership
Has primary accountability for operational study level time, cost and quality deliverables.
Lead the development of the clinical study plan including critical path activities and interdependencies for assigned clinical study utilizing Microsoft Project or equivalent.
Lead the creation of the cross-functional Clinical Study Oversight Plan (CSOP) under the guidance of the study team leader and take a leadership role in ensuring study team adherence to the CSOP and manage the overall implementation and documentation of the CSOP, including activities conducted by CROs and vendors.
Provide operational input into study protocol profiles, final protocols and amendments
Lead document review & coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.
Lead the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management.
Lead the creation of the CRO scope of work in collaboration with Outsourcing Procurement Management.
Lead trial feasibility and site identification activities in collaboration with the CRO and the study team. Oversee the site qualification process.
Triage, resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.
Ensure adherence to internal procedures for study planning, study conduct, close out and reporting.
Proactively assess potential risks to the study and propose mitigation plans.
Monitor study budget against trial progress and bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through costs.
CRO, 3 rd Party Vendor Management and Oversight
Responsible for the oversight, performance, and management of CRO and 3 rd party vendors to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Specifically track operational study timelines and monitor operational performance metrics trough the life of the study; Identify issues and propose solutions.
Responsible for ensuring that the CRO(s) provide timely input and generate documents in a timely manner and with quality (e.g. communication plan, site monitoring plan, etc.) as per study plan.
Responsible for overseeing CRO study start-up activities and coordinating with functional groups to ensure that essential site documents are collected, and sites are initiated per study plan. Oversee and track site initiation and enrollment activities at the country and site level and develop mitigation strategies in collaboration with the CRO.
Coordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training. Note that vendor management is not limited to the CRO, but includes 3 rd party vendors (e.g. translations, trial insurance, and central laboratory, etc.).
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
A Bachelor’s degree (preferred in Life Sciences) is acceptable. 5-6 years’ relevant experience is required with a BSc
Experience in clinical operations methods and processes in industry setting required.
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.
Familiarity to a Japan-based organization is desirable.
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.
Senior Clinical Study Manager
Clinical Development Operations