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Sr. Clinical Study Manager - Global operations Oncology

Company name
Apex Systems Inc

Location
Basking Ridge, NJ

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Job Description
Duties:  \r\r\rResponsible for operational study strategy and study management execution, in addition to managing direct reports. \rDevelop project based cross-functional, integrated study plans to study start up (in-house), and validate and manage the overall study implementation plan provided by the CRO. Participate in site selection and site qualification with study team and CRO\rLead the Study team along with contributing 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.\rEnsure meeting logistics, agenda and minutes are in accordance with internal standards.\rAct 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. \rOversee 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.\rOversee CRO study start-up activities and coordinate with functional group to ensure that essential site documents are collected and sites are initiated per plan.\rCoordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings and investigator meetings and training.\rManagement of vendors is not limited to the CRO, but includes ancillary vendors (e.g. translations, trial insurance, and central laboratory).\rWork closely and oversee CRO activities for study execution with CRO on a task and operational level per the project plan. Oversee CRF completion and monitoring; Triage, resolve or escalate study issues to the supervisor.\rOversee 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.\rConfirm internal tracking systems are updated (e.g. Global Project Management System, GPMS).\rEnsure 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.\rFocus 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.\r\r\r\r\rRequirements:                     \r\r\rA Nursing diploma or Associates degree required; A Bachelor’s or Master's degree in a Scientific field preferred\r5 years relevant experience managing a study team; 2 years experience working with Oncology studies required\rKnowledge of Phase Ib/II/III Oncology trial experience a must\rGlobal trial experience strongly preferred\rGlobal Study Leadership of Pivotal NDA filing studies highly preferred\rPMP or CCRA certifications desired\rExperience working in both sponsor and CRO organizations strongly preferred\rRelevant experience 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.\r\r\r***For immediate consideration, please email your updated resume to Apex Life Sciences at kschott@apexlifesciences.com with 'Clinical Study Manager' in the subject line.\r\r\r\r\r\r\r\r\r\r\r\r\r\r\r\rEEO Employer\r\rApex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.\r\r\r\r\r\r\r\r\r\r\r\r\r\r\r\r\r\rEEO Employer\r\rApex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

Company info

Apex Systems Inc
Website : https://www.apexlifesciences.com/

Company Profile
Apex Life Sciences is a division of the 3rd largest clinical/scientific staffing and services firm in the U.S. We match top scientific, engineering, and clinical research professionals at all career levels for contract, contract-to-hire, and direct hire opportunities.

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