Clinical Protocol Manager
|Reference # :||18-02226||Title :||Clinical Protocol Manager|
|Location :||Lawrenceville, NJ|
|Experience Level :||Start Date / End Date :||03/19/2018 / 09/18/2018|
Job Title : Clinical Protocol Manager/ Imaging Operations Lead.
Location: Lawrenceville, NJ
Duration: 6 months (might be extended)
Work Authorization: W2
Job Number: 22742-1
Resource needed to support a new book or work, including up-investment studies Opening is for Imaging Operations Lead.
Job Description: Drives the successful and timely execution of a clinical protocol from study startup to final clinical study report within established budget and timelines using strong project management and organizational skills, monitors protocol progress and addresses and manages obstacles, serves as primary operational contact for the protocol, coordinates the development of protocol level documents and plans, effectively leads a global team of individuals assigned to the protocol.
Provides project management and operational support for the imaging component of multiple clinical trials across all therapeutic areas.
Primary Responsibilities: Provides project management and operational support for the imaging component of multiple clinical trials across all therapeutic areas. Tactical operations resource for clinical teams supporting: imaging site and core lab selection; KOL/corelab interactions; protocol/imaging document development/review; operational guidance to team and sites; RFP review; team training/education; ensure delivery of image data per pre-defined timelines and specifications; risk management; imaging issue resolution; BASAR/MAC/CSP administration. Supports due diligence efforts required to qualify imaging core labs, as well as sites, for participation in both novel and strategic BMS relationships requiring imaging capabilities. Liaises with imaging core labs and external imaging SMEs to enhance the value of the relationship and capabilities to BMS needs; ensuring BMS gets best-inclass service from the vendor/SME on a global level. Partners with the key stakeholders to develop and align BMS imaging standards. Ensures program level processes and plans are developed to secure consistency across studies within an imaging paradigm. Support of image management systems in ECTR (IBISimg), responsible for driving user requirements, evaluating enhancements, ensuring compliance, prioritizing maintenance, user access control/review, and management of clinical trial images and related data. Establishes trust and builds successful relationships with key internal and external stakeholders at all levels. Through the use of effective communication practices, clarifies expectations, seeks to understand the needs of others and proactively provides status updates keeping stakeholders informed and up to date. Proactively, seeks feedback from stakeholders on the performance of self and team, operational processes and ways to optimize relationships. Demonstrates strong working knowledge of internal BMS systems, SOPs and Clinical Trial processes; uses effective negotiation skills, diplomacy and tact and leverages those competencies to ensure continuous progress with the imaging core labs thus moving issues to resolution. Applies broad business knowledge to ensure that decisions are taken in full context of BMS and the imaging core lab perspectives; ensuring balance between needs of the broader relationship vs. those of an individual team or function. Fosters teamwork between BMS functional areas and imaging core labs; creating a team environment based on mutual trust and respect. Encourages teams to share knowledge, experiences, best practices, and information on an ongoing basis and actively captures that knowledge for re-use and continuous improvement. Willingness to travel (5-10% of time) to build relationships and review onsite capabilities.
Experiences Desired: Experience with various imaging modalities incorporated and implemented in clinical trials for drug development Minimum of 6 years of experience in clinical or image-related project management. Demonstrated ability to manage multiple simultaneous projects of global scale – ontime, within budget. Demonstrated ability to analyze and interpret complex problems/data from a variety of sources, and through effective decision-making and planning, deliver superior business results .Prior experience working in a highly matrixed environment requiring sophisticated stakeholder and relationship management.
Knowledge equivalent to that attained with a Medical Imaging Certification or Bachelor’s degree in Imaging, Life Sciences, Health or related area and 4+ years related clinical/industry imaging experience; Masters degree with 4+ years imaging-related experience; or PharmD/PhD with 2+ years imaging-related experience. Understanding of Good Clinical Practice (GCP)and international regulatory environment. Thorough understanding of organizational structure, operating culture, effective work styles and achieving results in a changing environment. Knowledge of data management, design and statistical analysis process. Ability to influence in the matrix and across organizational/company boundaries. Thorough understanding of company policy for engaging vendors, project management, image and data delivery.
If hired, you will enjoy the following Eclaro Benefits:
If you feel you are qualified with the required skills and if you are interested, please free to send your word version most updated resume TAILORED to the job description above to June@eclaro.com