Clinical Study Lead (Local Candidates Only)

Hi,Abhay this side. We do have a new an excellent opportunity for you. This opportunity is a Contract position of Clinical Study Lead. Please have a look at the job description below and let me know if you or someone you know is interested in this role. You can mail me at adubey@shiftcodeanalytics.com

Job Title: Clinical Study LeadJob Location: Basking Ridge, NJ / Tarrytown, NY (Hybrid) (Preferred Local Only)Job Type: Contract Job Description Leads the cross-functional study team responsible for clinical study/research collaboration delivery and is the primary point of contact of leadership and oversight (as required) for the assigned studyProvides operational input into research plan and/or study protocol developmentEnsures development of study specific documentation such as samples management plans and data management plans are completed on time and in accordance with the study protocol.Oversees set-up and maintenance of study systems which may include Clinical Trial Management System (CTMS), Trial Master File (TMF), study SharePoint etc.Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors, if appropriateProvides input into baseline timeline development and managementProvides input into baseline budget development and management, facilitates internal review of the study budget for assessment of Fair Market ValueEnsures accurate budget management and scope changes for internal and external studiesEscalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issuesOversees the execution of the clinical study against planned timelines, deliverables and budget JOB f 2Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of workManages and oversees study close-out activitiesEnsures End of Study Summary is delivered and properly archivedFacilitates and contributes to study level lessons learnedAssigns tasks to Clinical Study Management staff and supports their deliverablesRecommends and participates in cross-functional and departmental process improvement initiativesResponsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement departmental processes and proceduresWorks with Therapeutic Focus Area groups within Basic Research/DiscoveryWorks closely with clinical site staff, predominatly at academic institutionsExpected to maintain higher volume and/or greater complexity studiesExpected to communicate learnings, best practices and relevant information to other study leads at all levels, ensures consistency and internal alignment across staffMay be responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversightIn order to be considered qualified for this role, a minimum of a Bachelors degree with 8+ years relevant industry experience. Sponser experience and site experience preferred.

Thanks & Regards, Abhay DubeyShiftCode Analytics Inc Tampa, FL E-mail ID: adubey@shiftcodeanalytics.com Direct: 725-527-2028 LinkedIn : linkedin.com/in/abhayy-dubey-a5425423a (Due to heavy call flow I may miss your call so email is the best way to reach me.)