Clinical Trial Leader

Company Description 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.

Job Description Job Purpose     Accountable for all aspects of assigned TCO medium to high complex clinical trials (Phase I/II) including leading Clinical Trial Team(s) (CTT). Responsible for program level activities as assigned. Major Accountabilities     1.
Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for medium to highly complex 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 Novartis 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 with minimal supervision 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 and Phase II data reviews 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. Assess resource needs with program and TCO management to ensure appropriate line function allocation.
8.
Sits on Early Program Team (EPT) to contribute to program strategy.
9.
Lead or be a key contributor to the development of program specific standards (e.g., CRFs, outsourcing specifications…