Clinical Program 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.

Leads the cross-functional execution of one or more clinical studies conducted within the Pharmaceutical Clinical Research Unit (PCRU)

Accountable to PCRU leadership and the Core Study Team for delivery of a PCRU study according to agreed quality, timeline and cost parameters

Assures that PCRU studies are conducted in compliance with GCP, relevant SOPs and local regulatory requirements

Assures data integrity and data quality for each assigned study through input to study feasibility and protocol development efforts, verification of EDCMS study set up, management of cross-study activities and coordination of PCRU functional line data review/verification activities (e.g., data verification, data cache review, data listing reviews, study report reviews)

Coordinates and contributes to the assessment and minimization of operational risks and to the resolution of operational issues

Promotes best practices within and across PCRU studies to drive operational excellence

Responsibilities:

• Responsible for study/project management within the unit including study scheduling, protocol planning(start up activity) and is the the primary contact for the project teams responsible for the compound/project - from the time of the Study/project document is drafted until the data base/project is locked.

• Leads PCRU cross-functional input to, and review of, the Study Protocol prior to finalization

• Serves as primary liaison/point of contact for the Core Project Teams/Pharmaceutical Clinical Research Unit (PCRU)

• Develops and ensures adherence to study timelines

• Coordinates and reviews all study activities

• Serves as primary point of contact for on study decisions related to the protocol, data collection and volunteer activities

• Partners with line leaders and functional staff across PCRU departments

• Maintains accuracy, accessibility and confidentiality of all volunteer records and reports

• In depth review of all clinical data, serves as study monitor, ensures all data is complete and checked before databse lock and release

• Leads the data integrity/data quality activities for assigned protocols

• Provides critical assessment of strategic partner and vendor proposals to ensure study success

• Reviews site level clinical trial budget

• Leads other functions and strategic partners to ensure timely delivery of quality data

• Oversees the overall execution of clinical studies

• Participates in study meeting with relevant partners for operational alignment

• Communicates opportunities and risks to the Core Project Teams for integration in risk management plans

• Effectively coordinates all functional areas involved in clinical trials to solve problems and assure progress and timely completion of study goals.

• Responsible for ensuring clinical trials are conducted in accordance with scientific, medical, and ethical principles, and within regulatory requirements/guidelines. Responsible for volunteer safety and accurate interpretation and execution of research protocols including multiple study activities

• Leads the clinical study components with respect to time, operational feasibility, and study-level PCRU resources required to deliver individual studies against the development plan (part of the study budget)

• Assesses impact of technologies required to deliver clinical trials and incorporates the development of these technologies into the clinical studies to ensure conduct and data collection suitable for purpose

• Provides support for Methodology/Mechanistic studies as appropriate

• Partners with Core Project Teams to provide study schedule and budget information to enable project management

• Identifies performance/quality issues to develop appropriate remediation plan

• Identifies…