Clinical Science Manager

Title:- Manager, Clinical Science - Contractor

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Location: Basking Ridge, NJ (Hybrid or 100% remote is acceptable)

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Duration: 6 months Contract (Possible extension, budget/performance dependent)

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Description / Responsibilities

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Hours Per Week: 30-40 hours (average 35 hours per week) – but could work 40 per week hours as needed.

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JOB SUMMARY

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Under guidance of Clinical Science Lead (CSL) and/or Medical Monitor, drafts development plans, protocol profiles, protocols, informed consent forms, and clinical sections of submission documents. Performs study level data cleaning of listings and patient profiles. Represents Clinical Science on Study Team and collaborates as a team member with other functions, AROs, and CROs. As part of the clinical team, provides scientific input to Clinical Operations and other functions. This position provides critical study-level support to the CSL/PS/MM/GCL for the successful execution of assigned studies.

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Responsibilities

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Study Strategy: Under guidance of CSL and/or Medical Monitor, drafts development plan.

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Supports CSL and/or Medical Monitor in development of study design to meet study objectives.

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Contributes to provide strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan and to Clinical Operations on SDV plan.

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Participates in the development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP).

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Provides input to the Integrated Data Review Plan process with Data Management. Performs literature review and creates reference list for study.

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Study Planning and Execution: Contributes to clinical trial planning including identification of potential risks to study deliverables and contingency planning.

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Supports development of protocol profile, protocol, and ICF template.

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Participates in the selection of ARO, CRO, and members for DSMB and/or adjudication committee and the development of charters for study committees (e.g., Executive Committee).

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Provides input to Clinical Operations on monitoring plan (e.g. data fields to be SDV’d), to Data Management on the Integrated Data Review Plan, and to Biostatistics on Statistical Analysis Plan (SAP).

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Reviews patient demographics, enrollment, retention and protocol compliance.

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Study outputs: Reviews emerging clinical data regularly.

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Performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update, as needed.

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Provides input to Clinical Operations on site issues.

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Contributes to development of CSR.

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External collaboration: Participates in discussions with internal experts and external KOLs for protocol development.

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Participates in the review of CRO and ARO Scope of Work and budget.

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Participate in study team meetings with CRO and ARO.

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Contributes to establish effective communication with CRO, ARO, and vendors.

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Additional non-study related activities: Performs literature review related to new indications for Life Cycle Management.

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Education

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Bachelor's Degree

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in life sciences or related field

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Master's Degree

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or equivalent

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PharmD

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or equivalent

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PhD

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or equivalent Postgraduate training in TA or related specialty, or equivalent

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Experience Details

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1-3 years of relevant clinical experience with advanced degree (PharmD, PhD)

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3 or more years of relevant clinical experience with Bachelor’s degree.

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Technical Proficiency: Develop and demonstrate proficiency in necessary technical skills and tools. Be adept at preparing documentation and supporting materials for various clinical trial activities.

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Competencies

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Excellent oral and written communication skills, strong interpersonal skills; ability to work in a team environment; able to work in a high stress and deadline-driven environment. Energetic, self-motivated and able to multi-task.

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Specific competencies: Strategic Thinking, Clinical Trials Knowledge, Influencing Skills, Scientific Knowledge, Therapeutic Expertise, Critical Thinking, Project Management

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Thanks

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MINAKSHI SANGWAN

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Recruiting Lead - US Recruitment

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O 732-339-3518

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E Minakshi.sangwan@aequor.com

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W http://www.aequor.com/

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