Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
• 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 on-site clinical oversight and management for clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during use of the company’s medical devices during clinical investigations and post-market studies
• Communicates with 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 the Clinic, Research and Development, Advanced Development, 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
• Bachelor’s degree in a health profession or science. Advanced degree preferred.
• At least 5 years of on-going clinical trials experience in the pharmaceutical industry.
• 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.
Language and Verbal Skills
Individual must have good verbal skills and written skills plus a demonstrated ability to communicate clearly and professionally.
Analytical and Reading Skills
Ability to read analyze interpret and assist in the creation and refinement of company procedures. Ability to identify problems, collect data, draw valid conclusions, and report on findings. Ability to assist in analysis of clinical trial data. Ability to interpret articles published in medical and scientific journals relative to projects and activities in Clinical Programs. Responsible for ensuring accuracy of medical and scientific information.
While performing the duties of this job the employee may be required to perform tasks involving lifting weights of up to 30 pounds for short durations. Duties of this job may involve standing and/or walking for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision. Duties will also include air travel both domestically and internationally.
Valeant is an EEO/AA employer M/F/D/V.
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