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Clinical Trial Manager - early phase

Company: DOCS
Location: Harrisburg
Posted on: April 8, 2021

Job Description:

Clinical Trial Manager - early phase **Ref #:** 27612 **Employment type:** Permanent - Full-Time **Location:** Home-based remote **Posted:** 12-Mar-2021 **Description** If you are looking for the opportunity to work as a home-based Clinical Trial Manager, this is a great opportunity to work with a global pharmaceutical company. - Serves as the key operational contact with external investigators and internal stakeholders, for successful implementation of company, collaborative, Investigator Sponsored Research (ISR) Studies, expanded access programs, and compassionate use programs - Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility and fair market value assessment - Establishes strong partnerships with external investigators and collaborators to ensure ongoing activities (e.g. sponsor updates, drug shipments, publications, milestone payments, etc.) for collaborative and ISR studies are executed in a timely manner and with high quality - Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure study remains on track - Implements and maintains working processes to promote high quality, efficient, and compliant systems and tools for collaborative and ISR study management - Maintains a good understanding of industry standards and regulations for collaborative and ISR studies and keep abreast of any new changes and developments impacting Late Phase clinical operations. - Organizes and leads clinical operational meetings - Maintains internal Clinical Operations databases and document repositories - For company studies, drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, and clinical study reports - Must be able to understand, interpret and explain protocol requirements to others - Maintains study timelines - Coordinates review of data listings and preparation of interim/final clinical study reports - Assists in determining the activities to support a project's priorities within functional area - For company studies, contributes to development of RFPs and participates in selection of CROs/vendors - For company studies, might be asked to train CROs, vendors, investigators and study coordinators on study requirements - Contributes to development of study budget - May serve as a resource for others within the company for clinical trials management expertise - Able to examine functional issues from an organizational perspective - Participates in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development - May contribute to development of abstracts, presentations and manuscripts - Under supervision, may design scientific communications within the company - Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision - Must have a general, functional expertise to support SOP development and implementation - Travel may be required - Collaborates with local medical affairs colleagues on country specific studies and initiatives - Provides knowledge and expertise on country specific regulations, site experience, and suitability for development studies Qualifications: BA/BS Degree required 3+ years of Clinical Trial Management experience in a Pharma/CRO setting Phase I experience required DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry. DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment. \#PMjob

Keywords: DOCS, Harrisburg , Clinical Trial Manager - early phase, Healthcare , Harrisburg, Pennsylvania

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