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Daiichi Sankyo US · 1 day ago

Senior, Clinical Study Associate

Basking Ridge, NJ

Full-time

Onsite

Mid, Senior Level

$99K/yr - $149K/yr

2+ years exp

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies. The Senior Clinical Study Associate will assist in planning and execution of clinical studies, ensuring compliance with protocols and regulations while providing administrative support to study teams.

Health CareTherapeuticsWellness

Comp. & Benefits

Responsibilities

Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan

Distribute key study documents to the CRO and vendors as appropriate

Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings

Support Fair Market Value process in evaluating study budgets

Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov)

Under supervision, review and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor

Compile and maintain a monitoring review spreadsheet

Compile and maintain CRO Oversight Monitoring (CROOM) visit output

Analyze study site metrics reports to identify potential areas of concern and bring to supervisor’s attention

Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to your supervisor

Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices)

Works with Insurance Brokers to obtain study site Insurance

Provide tracking and oversight to the Vendor handling lab logistics and any other vendors deemed appropriate

Participate in training; make recommendations for areas of improvement and innovation (study, or departmental level). Work with supervisor to provide input into individual career development plan

Qualification

Clinical developmentClinical Practices (GCP)FDA regulationsInternational Conference on Harmonization (ICH)Clinical trial managementLife Sciences degreeCRO experienceData analysisCommunication skillsOrganizational skills

Required

Bachelor's Degree (preferred in Life Sciences) with relevant clinical development experience required

2 or more years work experience with bachelor's degree 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)

Ability to travel up to 5% In-house office position that may require occasional travel