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Biomarker Trial Manager
Ref No.: 18-01282
Location: East Hanover, New Jersey
Start Date / End Date: 06/18/2018 to 12/18/2018
1. Support individual clinical trial teams (CTTs) and Biomarker Sub-teams as required for all tech-nical and operational biosample-related matters for assigned projects by liaising with internal stakeholders. Assist Study Lead by forecasting the biosample operational costs and reviewing in-voices.
2. Provide input on biomarker and clinical pharmacology sections in clinical trial-related (such as protocols and consents) and regulatory documents (such as INDs, IBs, etc.) under the supervision of the LF representatives.
3. Responsible for all clinical biosample tracking processes, including setting up laboratory proce-dures, tracking clinical biosamples from collection to analysis, and assisting with the relevant data management components.
4. With support, provide input and solutions on the ethical considerations for biosample collection and analysis for protocols and consents to ensure that all specific processes needed for approval in different countries are implemented.
5. With support, establish central and analysis laboratory components for assigned studies. Oversee central labs and analysis labs for clinical, biomarker and PK sample collection kits and sample lo-gistics. Responsible for all of the documentation required to set up central and analysis lab proce-dures.
6. Liaise with internal stakeholders, and the CTT to determine analysis labs for biomarkers and other clinical biosamples. Manage relationships with analysis labs and provide input into trial-specific agreements, following the standard process.
7. Define biosample needs for the case report forms (CRFs), in collaboration with LF representatives, Study Lead, trial data manager (TDM) and analysis labs; and for data formatting and data transfer set-up needs for samples. With support, liaise with the trial data manager (TDM) and labs for data transfer and data reconciliation
8. Partner with Global Correlative Science Leader (GCSL), study biostatisticians, and labs to estab-lish biomarker analysis plan; under guidance, review transferred data to ensure quality.
9. Develop, with assistance, training material on the technical aspects of clinical biosample collec-tions for the clinical sites, including study specific lab manuals and additional site and monitor training needs. May also be involved in training of monitors and site personnel.

At least 2 years of experience handling clinical samples

Familiarity with biomarker discovery methodologies, assay technologies and molecular biology.

Basic knowledge of oncology or hematology strongly preferred
Knowledge of Good Clinical Practice

Basic knowledge of clinical trial design; understanding of the overall drug development process
Excellent organizational and communication skills

Ability to manage multiple competing priorities and meet timelines

Proven networking skills and ability to share knowledge and experience amongst colleagues.

MSc or equivalent is preferred.