- Daiichi Sankyo
- $29,400.00 -38,710.00/year*
18 Brentwood Ct
About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.Job Summary
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.
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 Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require the Sr. CSM to take the role of both operational strategy and study execution, in addition to the responsibility of managing 0 to 2 direct reports.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 implementation 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 lead document review & coordination 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 are in accordance with DS standards. At this level, the incumbent will be expected to be able to lead the cross functional study team. 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.
CRO and Quality Oversight
- Ensure DS internal tracking systems are updated (e.g. Global Project Management System, GPMS).
- 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 trough the life of the study; Identify issues and propose solutions. Proactively assess potential risks to the study and propose mitigation plans.
- Monitor study budget against trial progress and bring deviations to the Delivery Lead (Director/Assoc Director). 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 leadership 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, propose solutions, or bring to the attention of the supervisor. Coordinate and liaise with Daiichi Sankyo QA on audit activities.
Knowledge Management/People Management
- 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.
- This position may require the supervision of 1-2 direct reports. In addition to providing instruction, direction of daily activities in support of goals, the supervisor will conduct a performance evaluation against development goals and career path requirements for their direct reports. The supervisor should coach and guide their direct reports in support of their development needs, and facilitate conflict resolution on their behalf.
- 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.
- A Bachelor's degree in the Sciences is acceptable.
- Candidates with a nursing diploma/assoc degree with substantial experience may be considered for this position.
- 5 years relevant experience is required with a BSc, 3 years with a MS/MPH, or 2 years with PharmD/PhD
- 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.
Senior Clinical Study ManagerCity
Basking RidgeFunctional Area
Clinical Development OperationsState
Associated topics: disease, health, healthcare, immunohematology, immunology, microbiological, nutrition, pharmacology, transfection, vaccine
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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