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Biomarker Operations Project Manager

Technologie de l'information

440 jours | San Francisco, California, United States | CONSULTANT SPECIALISTS, INC. (CSI)

Biomarker Operations Project Manager

440 jours | San Francisco, California, United States | CONSULTANT SPECIALISTS, INC. (CSI)


Date de début :septembre 16

Appliquer avant :octobre 17 2020

Industrie : Technologie de l'information,

Type :Contrat (12 mois)

Description du poste

10219601 Biomarker Operations Manager II


W2 ONLY - 12 Month Contract


  • GCP

Position Purpose:

  • Provides biomarker operational expertise and guidance to one or more cross-functional global Study Management Teams (SMTs)
  • Ensures the timely and efficient delivery of all biomarker operational aspects of one or more studies through all phases (phase 1b-IV) supported by PD and stages (start-up, conduct and close-down), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.


Main Responsibilities and Accountabilities:

  • Provides biomarker operational expertise and guidance to global Study Management Teams (SMTs)
  • Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (including companion diagnostic samples) * (collection, processing, analysis, data delivery process and final sample disposition) .
  • Responsible for collaborating closely with biomarker scientists and Biomarker
  • Operations Program Leaders (BOPLs) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internal and external stakeholders.
  • Develops and maintains effective working relationships with SMT members, with particular

focus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors, where applicable

  • Builds and maintains effective and efficient high performing biomarker sample* analysis & data delivery . Supports relevant stakeholders in their accountabilities, responsibilities and deliverables to drive decisions on timelines
  • Responsible for the identification and selection of biomarker vendors in collaboration with the BOPL, biomarker scientist, GPPS and diagnostics/CDx managers; ensuring appropriate cross-functional input is incorporated into the scope of work
  • Ensure collection, delivery and analysis of biosamples under the highest standards of quality, ethics, and informed consent at study level
  • Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans,
  • Ensures biomarker operational tracking and project management tools are utilized to meet the needs of the operations team and ensures reporting to the Biomarker
  • Operations Program Leader (BOPL).
  • Supports the development of the biomarker analysis budget and manages it on a study level. Communicates variances in the budget to the BOPL or GSM as appropriate.
  • Establishes biomarker sample analysis and data delivery milestones and ensures accurate tracking and reporting of Biomarker sample* metrics.
  • Provides study level updates to stakeholders (BTALs & BOPLs), clinical study teams and biomarker teams including sample collection, assay status and analysis updates
  • Provides clinical biomarker operations expertise to ensure operational feasibility and delivery
  • Responsible for assessing feasibility for biomarker operations plans on clinical studies across related functions
  • Leads the development and finalization of the Biomarker Management Plan (BMP) based on input from scientific and operational stakeholders to execute biomarker operational strategies
  • Provides operational input and recommendations into all study related documentation (including protocol, informed consent form, and amendments) and processes.
  • Attends operations team meetings and investigator meetings, monitor training, CRO kick-off meetings, as applicable, to deliver presentations and in-depth trainings to internal and external stakeholders on biomarker and companion diagnostic sample collection and handling procedures
  • Provides responses to biomarker sample* related questions or issues from Health Authorities.
  • Provides biomarker* operational input into the development of protocol feasibility questionnaires to ensure sites can meet sample-handling needs for the study
  • Provides input into the development of SMT goals.
  • Delivers the operational elements of the biomarker management plan
  • Proactively manages biomarker sample analysis and data delivery timelines and communicates any variances to the SMT, BOPL and biomarker scientists and implements contingencies in consultation with key stakeholders.
  • Primary contact for internal and external stakeholders to maintain oversight of biomarker vendor performance, issues, their resolution and coordinates any corrective action in collaboration with GPPS.
  • Actively partners with Data Acquisition Specialists and Data Management to oversee and coordinate biomarker data format and delivery timelines
  • Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
  • Partners with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions, kit contents, shipping conditions and logistics for biomarker samples
  • Performs ongoing biomarker vendor management including development and oversight of scope of work, budgets (invoice review & reconciliation) and performance management
  • Serves as primary point of contact for laboratories performing biomarker analysis and hence supports the biomarker outsourcing process through effective vendor management
  • Identifies areas of best practice and process improvements
  • Participates in Product Development Global Operations initiatives and programs as assigned
  • May lead or be a representative on functional groups goals, initiatives and work-streams
  • Ensures study adherence to ICH/GCP and SOPs

*in some cases may also be applicable to bioanalytical samples in partnership with the bioanalytical managers

Technical Requirements:


  • Life sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required. Further qualification, e.g. PhD and/or project management certification is desirable.
  • 3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Skills & Knowledge:


  • Extensive clinical development experience with evidence of working in teams running clinical studies
  • Pharmaceutical industry experience or experience working as a clinical trial coordinator within a clinical trial setting is a plus
  • Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
  • Project management skills
  • Critical reasoning skills including the identification and resolution of complex problems
  • Detail oriented with the ability to work independently and manage multiple competing priorities
  • Planning, organizational and time management skills
  • Highly flexible in a fast pace global matrix environment
  • Professional interpersonal skills, excellent oral/written communication and influencing skills
  • Proven leadership skills, ability to successfully achieve results within a multi-cultural and geographically diverse team
  • Creates team culture and promotes team spirit.
  • Global Vendor Management experience preferred
  • Good knowledge of ICH GCP


  • Strategic Agility
  • Inspiring and Influencing
  • Teamwork and Collaboration
  • Communication
  • Technical and Business Expertise
  • Achieving Results


  • SOPS

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