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Biomarker Operations Project Manager
San Francisco, California, United States | CONSULTANT SPECIALISTS, INC. (CSI)
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Biomarker Operations Project Manager
Technologie de l'information
Biomarker Operations Project Manager
279 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
Work is ON-SITE in SOUTH SAN FRANCISCO
W2 ONLY - 12 Month Contract
- DETAIL ORIENTED
- DIVERSE TEAM
- PROJECT MANAGEMENT
- VENDOR MANAGEMENT
- 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
- 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
- Technical and Business Expertise
- Achieving Results
- PROJECT MANAGER
- TIME MANAGEMENT
- CLINICAL RESEARCH
- CLINICAL STUDIES
- CLINICAL TRIAL
- LEADERSHIP SKILLS
- LIFE SCIENCES
- PROCESS IMPROVEMENTS
- PRODUCT DEVELOPMENT