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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.
Title: Imaging Operation Lead
Duration: 6 months
Location: Lawrenceville, NJ
Provides project management and operational support for the imaging component of multiple clinical trials across all therapeutic areas.
· 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 Client and strategic Client's relationships requiring imaging capabilities.
· Liaises with imaging core labs and external imaging SMEs to enhance the value of the relationship and capabilities to Client needs; ensuring Client gets best-inclass service from the vendor/SME on a global level.
· Partners with the key stakeholders to develop and align Client 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 Client 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 Client 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 Client 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.
· 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.
· Candidate should be qualified with Bachelors(Required),Qualifications like Masters would be a bonus
Interested candidates can send their updated resumes on firstname.lastname@example.org and you can also reach me at 973-967-3431.
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