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Clinical Research Project Manager I

Company: Unicon Pharma
Location: Elizabeth
Posted on: September 13, 2020

Job Description:

Location: Somerville, NJ Duration: 06 Months Job Description: This individual will have strong scientific expertise to provide insights and strategic direction to develop innovative evidence generation and dissemination strategies (EGS / EDS) for New Product Development and Life-Cycle Management (NPD and LCM) projects. Overall Responsibilities: Reports to the Integrated Leader (VP) Preclinical, Clinical & Medical (PCM) for NeuWave Responsible for Clinical R&D activities for assigned projects, including: Develop and deliver appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant CR&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Preclinical, Regulatory Affairs, HEMA, R&D, etc), ensuring cross- functional alignment; Responsible for delivery of assigned clinical projects, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP); Ensure input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the EGS / EDS; Lead in study design to develop appropriate clinical trials to meet the NPD / LCM needs; Lead in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, CERs etc Contribute in clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections; Responsible for teams interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory Agencies, societies, associations, etc; Foster strong relationships with external stakeholders to shape and influence relevant policies, etc Partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement Be a subject matter expert in the development of clinical evidence in the cancer / interventional oncology therapeutic areas of interest Functional and Technical Competencies: Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations; Ability to provide strategic and scientific clinical research input across NPD and LCM projects, including complex and / or transformational projects; Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations; Comprehensive understanding of clinical trial regulations across multiple regions; Ability to lead teams to deliver critical milestones, including complex projects; Ability to collaborate across different functional areas within CR&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives; Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders; Leadership requirement ability to influence, shape and lead without direct reporting authority; Change agent in team development and progression; Experience in effective management of project budget processes Ability to stay current with evolving innovative minimally-invasive interventional oncology device-based therapies, including disruptive technology and associated clinical data Ability to apply understanding to help define and shape clinical evidence strategies in the interventional oncology space Leadership Competencies: Strong leadership required in alignment with Client Leadership Imperatives: Connect, Shape, Lead, Deliver as noted below. Connect - foster strategic partnerships with key internal & external stakeholders to ensure development and timely delivery of innovative EGS / EDS Shape build strong relationships with external stakeholders to shape and influence relevant policies Lead continually develop expertise to provide strategic and scientific clinical research capability Deliver ensure clinical programs are delivered on time, within budget and in compliance to regulations and SOPs Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times. Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer. Performs other related duties as required. Education & Experience Requirements: A Bachelors degree in Biological Science or related discipline A minimum of 8 years experience with BS, 3-6 years with MS or 3 years with Ph.D with related scientific / technical experience, including leadership / management role within Clinical Research. A demonstrated knowledge of minimally invasive cancer therapies, cancer pathophysiology, and interventional oncology for treatment of various solid tumors is preferred.

Keywords: Unicon Pharma, Elizabeth , Clinical Research Project Manager I, Executive , Elizabeth, New Jersey

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