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Suitable candidates will have a minimum of 8 years related experience in life sciences or medically related field, including 6 years of clinical development and 2 years of management experience.

Salary scale will depend on skills and experience.

BA/BS; MS, PharmD, MPH or PhD preferred.

Typical duties:

Prepares clinical protocols and amendments

Oversees or performs feasibility assessment for new clinical protocols

Oversees investigator's recruitment Ensures compliance with policies and procedures.

Develops and/or approves sample, country specific investigator-prepared and Ethics Committee-approved informed consents

Develops or approves monitoring plans

Contributes to the overall strategic planning of clinical development programs

Collaborates interdepartmental scientific and medical activities specific to implementation and conduct of protocols

Integrates study plans from other departments into an overall clinical trial strategy

Approves the design, format and content of CRFs, study guides and subject instructions

Oversees activities associated with clinical site start-up and ensure the collection and maintenance of essential documents

Ensures appropriateness of forecast for investigational product and clinical supplies

Develops and manages study and project budgets

Manages Investigator Meetings

Manages the overall Investigational product accountability and reconciliation process

Ensures that that CRF data queries are resolved Oversees work done by CROs, central labs and other vendors chosen for clinical development activities

Provides study-specific outsourcing specifications for RFPs

Ensures training of clinical staff

Supervises CRO relationships and performance

Resolves patient eligibility and protocol deviation issues.

Assists in preparation Clinical Study Reports, Annual IND safety reports, CTSURs and ASRs May monitor clinical sites for adherence to protocol and GCP