Lab Project & Database Manager (R1093670) in Valencia, CA at IQVIA™

Date Posted: 11/21/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Valencia, CA
  • Experience:
    Not Specified
  • Date Posted:
    11/21/2019
  • Job ID:
    R1093670

Job Description

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

RESPONSIBILITIES

Study Setup and Planning

  • Manage individual Sponsor contracted clinical trial projects as assigned.
  • Facilitate Seamless Study Set-Up:
    • Review study protocol and bid/budget information once a study is awarded.
    • Ensure initial meetings are conducted (e.g. document review meetings, Design, and/or Startup meetings) with sponsor to ensure client Protocol requirements are understood and applied to the design of the lab study as well as to relay lab processes to the client.
    • Consult and advise customer on best or most proper course of action as needed.
    • Develop, relay and implement the Project Management Plan and Risk Management Plan per study as applicable; Create cost containment measures.
    • Partner with Study Set-Up team to ensure quality of study set-up.
  • Participate in the proposal development process as applicable.
  • Participate in the business development processes as applicable to Project Services responsibilities.
  • Lead in the development of sponsor specific standards and/or program-specific procedures.
  • Ensure key milestones are met and appropriate resources are available.
  • Oversee the writing of protocol-specific laboratory instructional materials (e.g. manuals, flowcharts, etc.) and participate in the preparation and maintenance of the laboratory specification documents
    • Develop the database design requirements which include configuration (project specific kit contents, laboratory events, requisitions, medical reports), programming for full protocols and protocol amendments, and developing and maintaining client design standards as applicable in accordance with the requirements of the Clinical Protocol.  
    • Perform database configuration and programming review and approve verification unit testing
    • Collaborate with colleagues during planning & handover meetings regarding project timelines, and project-related issues focusing on capabilities within Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management.    
    • Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved.
    • Lead in the identification and resolution of service level issues and where issues affect other projects within and across programs to ensure that any solution is employed universally. 
    • Ensure lessons learned are considered, shared and improvements included in study design process. Oversee the writing of protocol-specific laboratory instruction manuals / participate in the preparation and maintenance of the laboratory specifications document for each protocol within a program as appropriate. 
    • As required, prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings.
    • Coordinate and mentor more junior staff; may assist in training new staff. 
    • Report on team performance against contract, customer expectations, and project baselines to management

Study Activity Monitoring and Closeout

  • Monitor Project Management Plan, timelines, and deliverables, including trend analysis of study specific data, budget and change orders.
  • Manage study scope changes and study budget.
  • Utilize available tools, metrics, and reports as part of global study monitoring and closeout.
  • Manage all service related issues and implement changes to plan as required.
  • Conduct meetings with internal departments as required to meet needs of study and closeout activities.
  • Monitor quality of study and proactively determine and implement solutions for any issues that arise.
  • Report study progress to internal and external clients.
  • Ensure lessons learned are considered, shared and improvements included in processes as applicable.
  • Build and own client relationship for assigned study and serve as a liaison between Sponsor and project teams.
  • Facilitate Communication with the Client.
    • Act as the single point of contact for client, both responding and triaging communications.
    • Lead and/or participate in key client facing meetings (investigator meetings, study meetings, etc.).

Project Documentation and Deliverables

  • Coordinate meeting agenda, document minutes, track actions, and provide status updates.
  • Oversee the writing of protocol-specific laboratory instructional documents (e.g. manuals, flowcharts) and participate in the preparation and maintenance of the laboratory specifications document for each assigned protocol.
  • Develop start-up plans including but not limited to a program/project monitoring and communication plan, including tracking of milestones and timelines, risk management and action logs. As required, prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings. Provide additional training to sponsor, CRO, and site personnel as required (telephone training, attendance at CRA training meetings, site refresher meetings, etc.).

Participate in Investigator Meetings and Training Activities

  • Represent Q2 Solutions at Investigator/ Monitor meetings, internal and external authorities of regulatory bodies, and other Face to face meetings.
  • Participate in external and internal audits/inspections as required.
  • As needed, administer study training to sites, CRA and sponsors and establish regular lines of communication with sites to manage on-going project expectations and issues.
  • All associates will be familiar with the safety, environmental rules and procedures applying to their job and take reasonable care for their own safety and that of other people.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in Life Sciences and/or related field preferred.
  • 1-5 years of experience in clinical trials/ hospital-funded research, project management or laboratory environment preferred
  • Central laboratory project management experience strongly desired

PHYSICAL REQUIREMENTS          

  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Regular sitting for extended periods of time.
  • May require occasional travel.
  • EEO Minorities/Females/Protected Veterans/Disabled

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1093670