Responsibilities:

• Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection and communication with clinical trial sites regarding all logistics including contract agreements, support materials and training

• Provides clinical oversight and management for clinical trials to facilitate compliance with local and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all company clinical investigations and post-market studies

• Communicates with vendors and clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up and close out study visits to ensure compliance with protocols and GCP requirements

• Collaborates on clinical data processing in accordance with departmental SOPs and guidelines

• Verifies, reviews and tracks CRFs and generates Data Clarification Forms (DCFs) for all missing or inaccurate data; ensure that data changes are properly implemented and captured in the database or data system

• Assists in the evaluation and analysis of clinical trial data to facilitate completion of clinical trial reporting requirements, including report writing, clinical photo-documentation, FDA and manuscript submissions

• Assists in tracking study specific payments

• Provides operational or work flow support to assure that departmental and cross functional systems and procedures are efficiently and correctly completed

• Collaborates on project teams, primarily with Clinical Operations, Research and Development, Safety, Clinical Trial Materials, Marketing, Regulatory and Quality/Compliance

• Leads or collaborates on technical writing projects which include white papers, abstracts, manuscripts, and literature reviews

• Liaison between internal and external stakeholders to facilitate cooperation of others

• Conducts presentations of clinical information concerning specific projects

• Works on projects of moderate-to-high degree of difficulty in which analysis of situation or data requires review of identifiable clinical factors and in which scientific and clinical perspectives should be incorporated

Qualifications:

• Bachelor’s degree in a Pharmacy or equivalent. Advanced degree preferred.

• At least 5 years of on-going clinical trials experience in the pharmaceutical or device industry.  Both is preferred.

• Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements.

• Knowledge of medical terminology.

• Ability to effectively work independently

• Excellent verbal and written communication skills plus computer proficiency (Word, Excel, Outlook) and data management experience.

• 10%-30% travel required.