Talent.com
Precision Medicine Operations Lead / Clinical Laboratory Study Manager

Precision Medicine Operations Lead / Clinical Laboratory Study Manager

ParexelNew York, NY, US
1 day ago
Job type
  • Full-time
Job description

Parexel Job Opportunity

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Works with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical Laboratory Project Management (CLPM) groups to ensure quality samples and data are delivered to support biomarker and non-biomarker evaluation and enable the translation of science to medicine. Will work closely with project managers (central and / or specialty labs) and lend expertise to clinical trial management (CTM) and CRO to ensure samples are collected per protocol and assist with resolving any sample related issues or queries. Additional responsibilities include overall project management in alignment with the core business strategy.

Operations Management

Study Team Support

  • Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders, such as working with Informed Consent Form (ICF) specialist in SKDL on ICF and other trial documents impacting samples and testing

Operational Support of Sample Analysis (including exploratory analysis)

  • Establishment, oversight, planning, and integration of all issues related to collection, processing, storage, shipping and transfer of samples and data, as well as reporting / billing for study related operations
  • Liaises with Precision Medicine Strategy Leads and other scientists by assessing vendors, forecasting sample operational costs, timelines and reviewing invoices to ensure alignment with budget plans
  • Data Acquisition and Management

  • Works closely with data management lead to determine how sample and testing data will be captured, blinded and transferred for clinical trials
  • Human Sample Management Flow and Compliance

  • Provides guidance to clinical teams and clinical sites regarding collection, storage, and shipping of samples acquired in the course of clinical trials or other human sample acquisition projects
  • Works with scientists and clinical team to ensure sample collection and usage is in compliance with study protocol and applicable ICF
  • Works closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed
  • Compliance with Parexel Standards

  • Complies with required training curriculum
  • Completes timesheets accurately as required
  • Submits expense reports as required
  • Updates CV as required
  • Maintains effective relationships with other platform lines, Business Units / Research Units, and enabling lines that facilitate effective portfolio delivery
  • Skills :

    Excellent written and verbal communication skills

    Resolve problems spontaneously and possess strong project management and organizational skills

    Work independently and proactively while still contributing to group initiatives and goals

    Good interpersonal skills and ability to work with many different groups / teams

    Microsoft applications

    Knowledge and Experience :

    6 - 8 years clinical research experience with academic, CRO or pharmaceutical / biotech industry. We are seeking a professional with working knowledge of clinical trials and clinical databases. Laboratory sample management experience is a plus.

    Education :

    Bachelor's degree in a life science, nursing qualification or other relevant experience required.

    EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

    Create a job alert for this search

    Laboratory Medicine • New York, NY, US

    Related jobs
    • Promoted
    ED, Personalized & Precision Medicine

    ED, Personalized & Precision Medicine

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    This position will be located in the East Hanover, NJ site.The Insights and Decision Science (IDS) team is dedicated to enabling improved decision. We collaborate closely with the US business, bring...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Radiology Tech in Neptune, NJ

    Travel Radiology Tech in Neptune, NJ

    AlliedTravelCareersNeptune, NJ, US
    Full-time +1
    AlliedTravelCareers is working with Lancesoft Inc.Rad Tech in Neptune, New Jersey, 07754!.We are currently seeking qualified candidates for Radiology / Imaging. Shift 5x8 Evenings, 14 : 00 : 00-22 : 00 : 00, ...Show moreLast updated: 12 days ago
    • Promoted
    Laboratory Manager

    Laboratory Manager

    Atrium StaffingNew York, NY, US
    Full-time
    Our client is a prestigious Health and Wellness clinic looking to add a.We are looking for a hands-on, experienced Laboratory Manager to lead day-to-day operations at a busy clinical lab in Manhatt...Show moreLast updated: 4 days ago
    • Promoted
    Medical Science Liaison (MSL) ONC Solid Tumors W PA / E OH / N WV / Buffalo & Cleveland Remote (Open)

    Medical Science Liaison (MSL) ONC Solid Tumors W PA / E OH / N WV / Buffalo & Cleveland Remote (Open)

    Novartis Group CompaniesEast Hanover, NJ, United States
    Remote
    Full-time
    The Medical Science Liaison (MSL) role is a field based, customer-facing, non-promotional medical and scientific position. The MSL's key objective is to create impact through advancing clinical prac...Show moreLast updated: 17 days ago
    • Promoted
    Associate Director of Pathology

    Associate Director of Pathology

    Staff IconsBrooklyn, NY, US
    Full-time
    Associate Director of Pathology Brooklyn, NY Job Description Participates in internal / external quality assurance, performance improvement activities and programs, departmental and team / committee me...Show moreLast updated: 18 days ago
    • Promoted
    Travel Director - Medical Lab Technician

    Travel Director - Medical Lab Technician

    PRIDE HealthPompton Plains, NJ, US
    Full-time
    PRIDE Health is seeking a travel Medical Lab Technician Director for a travel job in Pompton Plains, New Jersey.Job Description & Requirements. Under the direction of the Laboratory Director, th...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Radiology Tech - $1,977 to $2,272 per week in Neptune, NJ

    Travel Radiology Tech - $1,977 to $2,272 per week in Neptune, NJ

    AlliedTravelCareersNeptune, NJ, US
    Full-time
    AlliedTravelCareers is working with Fusion Medical Staffing to find a qualified Rad Tech in Neptune, New Jersey, 07753!.Facility in Neptune, New Jersey. Fusion Medical Staffing is seeking a skilled ...Show moreLast updated: 12 days ago
    • Promoted
    Director, Division of Infectious Diseases

    Director, Division of Infectious Diseases

    Hackensack Meridian HealthNeptune Township, US
    Full-time +1
    Director, Division of Infectious Diseases.Jersey Shore University Medical Center.Hackensack Meridian Health – Neptune, New Jersey. Hackensack Meridian Health is seeking a Director, Division of...Show moreLast updated: 23 days ago
    • Promoted
    Medical Science Liaison (MSL) ONC Solid Tumors VA / DC / MD Remote

    Medical Science Liaison (MSL) ONC Solid Tumors VA / DC / MD Remote

    Novartis Group CompaniesEast Hanover, NJ, United States
    Remote
    Full-time
    The Medical Science Liaison (MSL) role is a field based, customer-facing, non-promotional medical and scientific position. The MSL's key objective is to create impact through advancing clinical prac...Show moreLast updated: 17 days ago
    • Promoted
    Associate Director Laboratory Operations

    Associate Director Laboratory Operations

    Staff IconsHicksville, NY, US
    Full-time
    Associate Director Laboratory Operations Hicksville, NY Day shift In this role you will : Develops and implements strategic planning of laboratory operations to support corporate goals including cha...Show moreLast updated: 23 days ago
    • Promoted
    Lead Clinical Lab Technologist - Blood Bank

    Lead Clinical Lab Technologist - Blood Bank

    Staff IconsValhalla, NY, US
    Full-time
    Lead Clinical Lab Technologist - Blood Bank Valhalla, NY Mon-Fri 3pm-11 : 30pm The Lead Clinical Technologist is responsible for performing, evaluating, and reporting of technical laboratory procedur...Show moreLast updated: 23 days ago
    • Promoted
    Travel Rad Tech - $2272 / Week

    Travel Rad Tech - $2272 / Week

    Fusion Medical StaffingNeptune, NJ, US
    Full-time
    Fusion Medical Staffing is seeking an experienced Rad Tech for an exciting Travel Allied job in Neptune, NJ.Shift : Inquire Start Date : ASAP Duration : 18 weeks Pay : $2272 / Week.Facility in Neptune,...Show moreLast updated: 11 days ago
    • Promoted
    Travel Radiology Tech - $2,724 per week in Neptune, NJ

    Travel Radiology Tech - $2,724 per week in Neptune, NJ

    AlliedTravelCareersNeptune, NJ, US
    Full-time
    AlliedTravelCareers is working with talent4health to find a qualified Rad Tech in Neptune, New Jersey, 07753!.Talent4Health is the most candidate-centric agency in the industry.Talent4Health has cl...Show moreLast updated: 9 days ago
    • Promoted
    DIRECTOR OF CLINICAL DIAGNOSTICS & LABORATORY INNOVATION

    DIRECTOR OF CLINICAL DIAGNOSTICS & LABORATORY INNOVATION

    Staff IconsBrooklyn, NY, US
    Full-time
    DIRECTOR OF CLINICAL DIAGNOSTICS & LABORATORY INNOVATION SALARY RANGE BETWEEN $150,000 TO $200,000POSITION SUMMARY The Director of Clinical Diagnostics and Laboratory Innovation is responsible for ...Show moreLast updated: 22 days ago
    • Promoted
    Travel Nuclear Medicine Tech - $3,115 to $3,308 per week in Freehold, NJ

    Travel Nuclear Medicine Tech - $3,115 to $3,308 per week in Freehold, NJ

    AlliedTravelCareersFreehold, NJ, US
    Full-time +1
    AlliedTravelCareers is working with Aya Healthcare to find a qualified Nuclear Medicine Tech in Freehold, New Jersey, 07728!. Aya Healthcare has an immediate opening for the following position : Nucl...Show moreLast updated: 1 day ago
    • Promoted
    Quality Laboratory Manager

    Quality Laboratory Manager

    Atrium StaffingFreehold, NJ, US
    Full-time
    Our client is a well-established manufacturing and laboratory facility near a major Midwest metro area seeks a dedicated professional to join its leadership team. This facility supports regulated pr...Show moreLast updated: 5 days ago
    • Promoted
    Director / Senior Director Biostatistics

    Director / Senior Director Biostatistics

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    As the Director / Sr Biostatistics, you will influence and drive statistical strategy / innovation directly taking part in cross-functional collaboration and decision making for program(s) across multi...Show moreLast updated: 30+ days ago
    • Promoted
    Prin Clinical Data Manager

    Prin Clinical Data Manager

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    Love clinical data management? Bring that passion to Novartis!.This key Principal Clinical Data Scientist will be responsible and accountable for managing all Data Management deliverables at a cons...Show moreLast updated: 30+ days ago