Clinical Trials Manager by stt79717


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									Position Title: Clinical Trial Manager
Company: BioPharmaceutical Company
Location: Near Chevy Chase, MD
Employment Type: Full Time Employee
Start Date: ASAP
Target Salary: Negotiable

Job Summary

The incumbent will be responsible for the planning and conduct of various clinical studies for compounds
within the company’s development pipeline. The candidate will manage multiple protocols and clinical
centers conducting various Phases of clinical trials in accordance with FDA regulations, SOPs and ICH
guidelines for Good Clinical Practice (GCP). Additionally, the incumbent will manage the performance of
CRO study team members by setting expectations, monitoring performance, providing feedback, and
following-up, when appropriate, with the Clinical Lead and the CRO Project Manager.

Primary Responsibilities

    •   Manages all aspects of study conduct, including protocol development, site selection, timeline
        and budget management, monitoring, safety reporting, clinical supplies maintenance, collection of
        data and regulatory documents, data analysis and preparation of study reports. May manage
        CRAs to assist with these processes.
    •   Acts as primary liaison with team members, consultants, vendors and investigative sites to
        ensure compliance with study protocols, adherence to GCP regulations, subject safety, quality of
        data and reliability of reporting.
    •   Plans study design and prepares clinical trial protocols, case report forms (CRFs), instructions for
        CRF completion, monitoring guidelines, and informed consent forms (ICFs); reviews statistical
        analysis and data management plans, assists with development of database edit checks, and
        contributes to writing of clinical study reports.
    •   Writes and reviews Investigator Brochures, Annual Reports to the Agency, IND/NDA submission
        documents, and assists with the writing and/or review of abstracts, presentations, manuscripts,
        and preclinical reports as needed.
    •   Develops and maintains tracking tools to monitor study timelines, budgets, regulatory document
        collection, clinical drug supply and other resources.
    •   Conducts contract and budget negotiation with study sites and vendors; evaluates cost proposals
        submitted by vendors; reviews and approves invoices; conducts vendor/site visits as needed to
        appraise performance and improve study operations; manages costs, projects and estimates
        anticipated costs; compiles and modifies budgets as needed.
    •   Manages the review of safety data and lab results with Medical Monitor(s) and facilitates initial
        and follow-up reporting of serious adverse events (SAEs) to the FDA.
    •   Ensures proper training of site staff and study monitors, including development of training
        materials and attendance at selected monitoring visits.
    •   Organizes regular team meetings and reviews monitoring trip reports to identify and address
        clinical issues.
    •   Coordinates with regulatory department to maintain on-site study files and performs audit of these
        files after closeout to assure that records are in compliance with GCP regulations.
    •   Assists in the creation of procedures to manage drug packaging, shipment, returns, transfer and
    •   Performs literature reviews and presents scientific updates on recent advances and competitive
        activity within relevant therapeutic areas.

    •   MS or Bachelor’s degree in health sciences or related field.
    •   A minimum of 5-8 years’ experience in clinical research and development with five years in
        clinical project management in the pharmaceutical industry with a proven track record for
        delivering clinical projects within time, budget and quality expectations.
    •   Strong knowledge of industry and FDA regulations, ICH, and GCP guidelines.
    •   Strong clinical study management skills, including risk assessment and contingency planning.
    •   Excellent analytical, communication, organizational and interpersonal skills.
    •   Also requires excellent leadership, communication and organizational skills, along with problem
        solving, and conflict resolution skills.
    •   Familiarity with the medical, scientific and clinical research techniques of the assigned areas.
    •   Experience using Microsoft Office Suite, with emphasis on Word, Excel, PowerPoint and Project

Please send me your updated resume with the following information at the earliest:
1. Full Name:
2. Current Location:
3. Availability to join:
4. Salary expectations:
5. Phone number:
6. Availability for interview:
** Will conduct a background check (verify employment, education and criminal)

Please email resumes to

Kind Regards,
Sarah Jones
Platinum Sponsors of PharmaSUG 2009
A Company with Innovative Mind

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