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PPD

Project Manager - Digital Specimen Management

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

 

Summary

Our client is developing a world-class Global Biospecimen and Imaging Management (GBSIM) organization within Global Development Operations (GDO) to drive excellence and innovation in end-to-end biospecimen and imaging management to support the objectives of both Research and Development. The operational oversight and management of the digital specimen strategy and lifecycle and precise vendor oversight to support these objectives is key.  
As such, we are recruiting for a Digital Specimen Operations Manager that will be responsible for providing project management, vendor oversight and operational support to the medical imaging component of multiple clinical trials across all therapeutic areas. Critical to this role is the ability to provide innovative solutions to oversee timelines for digital specimen data delivery and thereby, enabling quick decision-making and ensuring the client's continuous competitive advantage

As the GBSIM organization grows in scope and responsibility, primary responsibilities of this role may expand beyond medical imaging to include other digital specimen types.  Digital specimens are defined as a specimen, regardless of collection method that can be digitized to be viewed, analyzed, stored, indexed, and transmitted electronically.

Key Responsibilities and Major Duties of Digital Specimen Operations Manager:
•    Tactical operations resource for clinical teams supporting the imaging strategy and imaging vendor selection.
•    Interacts and liaises with imaging vendor project management teams and external imaging KOLs to enhance the value of the relationship and capabilities to client's needs; ensuring client gets best-in class service from the imaging vendor/KOL on a global level. 
•    Interacts with imaging client protocol management teams; attends regular protocol related team meetings and responsible for communicating imaging timelines/needs
•    Participates in protocol/imaging document development/review 
•    Provides operational guidance to clinical team and sites; clinical team training/education
•    Ensures delivery of image data per pre-defined timelines and specifications
•    Performs risk management and contributes to imaging issue resolution
•    Supports due diligence efforts required to qualify imaging vendor, for participation in both novel and strategic client relationships requiring imaging capabilities 
•    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 
•    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
•    Uses effective negotiation skills, diplomacy and tact and leverages those competencies to ensure continuous progress with the imaging vendor thus moving issues to resolution
•    Applies broad business knowledge to ensure that decisions are taken in full context of client and the imaging vendor 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 vendor; 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

*LI-SW1
Education and Experience:
  • Bachelor's degree in Life Sciences, healthcare related field or equivalent and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years’) or equivalent combination of education, training, & experience.
  • Experience is to be in an academic clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
Knowledge, Skills and Abilities:
  • Minimum 3 years pharmaceutical and/or CRO project management experience (imaging core lab and/or Imaging CRO preferred but not required); Digital Specimen Management (other than medical imaging) experience a plus.
  • Demonstrated experience working with internal and external stakeholders (vendor management). 
  • Demonstrated ability to manage multiple protocols/projects simultaneously. 
  • 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.
  • Knowledge of radiology response criteria used in oncology clinical trials preferred but not required (RECIST, etc.)
  • Strong written and verbal communication, presentation and organizational skills required.
  • Ability to operate in a complex matrix organization.
  • Must have a strong business partnering orientation with excellent analytic, interpersonal, and communication skill
  • Knowledge of ICH GCP and applicable local regulations governing clinical research along with basic medical and research knowledge.
  • Experience with various imaging modalities incorporated and implemented in clinical trials for drug development preferred.
  • Excellent networking skills with proven track record in the area of stakeholder and relationship management.
  • Professional inter-personal skills and excellent oral/written communication. Experienced in presenting logistics and processing instructions, including basic scientific and clinical content, to internal and external audiences.
  • Basic leadership skills in conflict management, facilitation and negotiation.
  • Proficient computer skills in Microsoft Office.
  • Experience with databases and intermediate-level Excel a plus
  • Up to 5 to 10% travel to build relationsips and review onstie capabilities
  • Strong verbal, written and presentation skills
  • Superior time management, planning, and organizational skills
  • Competent with specific computers and enterprise applications, including office productivity
  • Proven analytical skills
  • Demonstrated compliance with procedures and policies
  • Ability to perform multiple tasks effectively in a stressful environment
  • Strong client relationship management skills
 
Working Conditions:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
  • Able to use and learn standard office equipment and technology with proficiency.
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
  • Regular and consistent attendance
 
"Clinical site coordinator" , "study start-up", "end to end" , "project management" , "biospecimen management" , ICF, CFR, "vendor management" , "clinical trial"

 

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