• Lab Project & Database Manager Jobs in United States Of America - 23296019

  • Iqvia
  • United States Of America, Usa
  • Save Job
  • 1 - 5 Years
  • Posted : above 1 month

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 organizations clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it

PURPOSE

Under general direction, manage all laboratory aspects of clinical trial projects for a client or a specific program for a client; May have responsibility for a specific client, drug program, indication or drug compound; Act as main point of contact for the client after study award and throughout the entire study lifecycle (startup, maintenance, closeout)

RESPONSIBILITIES

Study Setup and Planning

Manage individual 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 (eg 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 (eg manuals, flowcharts, etc) and participate in the preparation and maintenance of the laboratory specification documents

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

Proactive lines of communication

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)

Coordinate customer survey follow-up / ongoing health check calls and overall client relationship building
Lead problem solving and resolution efforts in a timely, client-focused manner
Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles
Serve as a point of escalation for program level issues, while ensuring consistency of delivery on a global level
Coordinate and Triage Study-specific issues 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 Develop proactive contingency plans to mitigate laboratory risk
Escalate issues that impact the study plan or budget and relay any issues or trends to clients as applicable
Facilitate regular review meetings to discuss proactive problem resolution of study specific issues, utilizing the necessary resources from all relevant internal departments

Project Documentation and Deliverables

Coordinate meeting agenda, document minutes, track actions, and provide status updates

Oversee the writing of protocol-specific laboratory instructional documents (eg 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

Bachelors 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

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 IQVIAs Talent Acquisition team at workday_recruitingiqviacom to arrange for such an accommodation

Job ID R1084350

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Consulting Services
Functional Area : Engg. project Mgmt./site Engg./Civil Engg.
Role : Civil
Salary : As per Industry Standards
Deadline : 01st Feb 2020

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