Biosample Clinical Manager

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. 1.

• Support individual clinical trial teams (CTTs) and Biomarker Sub-teams as required for all technical 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 procedures, 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 logistics. Responsible for all of the documentation required to set up central and analysis lab procedures. 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 establish biomarker analysis plan; under guidance, review transferred data to ensure quality. 9.
• Develop, with assistance, training material on the technical aspects of clinical biosample collections 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. Skills: 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. Education: MSc or equivalent is required. Skills: 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. Education: MSc or equivalent is required. Warm Regards Neha Sharma
• Lead Recruiter Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: 973.967.3437 | Fax: 973.998.2599