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Job Title: Clinical Trial Leader 1
Location: Cambridge, MA
Duration: 3 Month Temp to Perm

Job Description:
Department: Translational Clinical Oncology
Accountable for all aspects of assigned TCO clinical trials (Phase I/II) including leading Clinical Trial
Team(s) (CTT).
 
Major Accountabilities
1.Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for clinical
    protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents
    and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors of the Client
    local organizations (CPOs) and investigators to ensure their feedback is adequately integrated into protocol.
2. Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates,
     IND/NDA submission documents, responses to Health Authorities questions.
3.  Investigator/site relationship management is vital; must develop effective working relationship with key investigators in assigned therapy area
     to optimize  scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards.
     Lead investigators meetings. Lead protocol training meetings and support CPOs in the conduct of regional meetings. Accountable for all internal
     clinical meetings related to the clinical trial(s).
4. Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are
     met according  to  timelines,  budget,  and  resource  requirements;  speaks  up  against  unrealistic timelines. Energizes CTT to adhere
     to global  performance and quality standards: chair CTT meetings, report study progress and issues with their resolution plan. Engages the
      input of line functions at the appropriate time. Leads trial level interactions with Global Monitoring Operations (GMO) and other relevant
      functions including Integrated Medical Safety and Drug Supply Management.
5   In collaboration with the CPL lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the
     development of clinical trial reports, publications and internal/external presentations.
6. Prepare and run dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data,
     including safety, efficacy, pharmacokinetic, imaging and biomarker data, to provide consolidated information for dose escalation meetings
     with investigators.
7. Forecast trial resources needs (external costs): accountable for the development,  management   and tracking of trial budget working closely with
     CRO  Management, with Clinical Trial Budget Managers and TCO Global Program Managers. Accountable for accuracy of trial information in all trial
     databases and tracking systems.
8.  Sits on early Program Team (EPT) to contribute to program strategy.
9.  Ensure that program specific standards (e.g., CRFs, outsourcing specifications including imaging, biomarkers PK, data monitoring, validation plans
     and data  transfer specifications) are applied to the clinical trial, where applicable.
10. Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties including central lab
      and imaging  vendors; manage interface with external vendors in cooperation with the CRO Management Department as well as with the Assay
       Research  Lab. This also includes the set-up, logistics, documentation and clinical supplies needed
11. For TCO trials, function as local trial leader (LTL), supported by the CPA, for all US activities including working closely with US GMO for all  study
       start-up  activities including regulatory documents, budget, contract agreements and all activities pertaining to updates as dictated by amendments.
       As the LTL, be the primary contact for US  sites for clinical conduct of the trial.
12. CTLs based in TCO Shanghai, support local CTA submission including validation of translation of protocols, amendments, ICFs, IBs etc. for TCO trials
       with  sites in China, supported by the CPA.
13. May participate in the on-boarding and mentoring of new TCO staff.
14. Contribute to the implementation of best practices and standards for trial management, including sharing lessons learned.
 
Key Performance Indicators
Planning, executing and closing of early phase trials on time and within budget
Adherence of GCP/ICH to ensure high quality trial conduct
Ongoing data review to promote trial decisions and strategic planning

Job Dimensions
Financial responsibility:   Responsible for financial/resource decisions within scope of assigned authority.
Impact the organization:  Well managed and effective trial team(s) resulting in the timely delivery of high quality clinical trial data and data analysis which enables strategic decisions within the clinical program.
seen  as  a  credible,  ethical  and  preferred  partner  by  key investigators in Oncology.