2726 Biomarker Operations Project Manager IV
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.
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.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.