Develops strategy, manages programs, and works with study teams to successfully implement start up for Phase 2-4 clinical trials. Formulates study and site-specific recruitment and retention tactics. Presents protocol and complex scientific information to clinical site personnel. Acts as liaison between Clinical Operations Department and clinical sites. Cultivates cooperative, long-term relationships with clinical sites. Conducts clinical site identification, protocol feasibility, subject recruitment and retention, and clinical study evaluations. Represents company at major therapeutic area scientific meetings.

Collaborate with pharmaceutical, biotechnology, medical device companies, and CROs to ensure successful clinical trial recruitment and retention campaigns, provide site feasibility and selection, and conduct clinical staff continuing education training. Build DAC’s reach by identifying new business opportunities, cultivating strategic partnerships, and managing existing client relations.

Identify, evaluate, qualify, and select new clinical investigators for pharmaceutical and medical device trials. Develop and deploy patient recruitment and retention campaigns which yield time and cost saving results.

Collaborate with Clinical Trial Management to plan and allocate human resources for global clinical trials.

Manage and coordinate the identification and verification of new adverse events and clarification of clinical database inconsistencies working with International and Domestic Clinical, Investigational Product Safety, Clinical Data Management and Biostatistics personnel to meet database close and lock targets.Identify discrepancies between protocols, CRFs and DCFs in the same therapeutic area and discuss with development teams to ensure justification of differences.Provide recommendations to improve efficiency and enhancing study quality working with International Clinical Study Monitors and Management.Draft Pharmaceutical Clinical Study Protocols and Clinical Study Reports as well as Clinical Evidence Reports for the International Medical Device group.

Prepared electronic US 510(k)s and PMA Annual Reports, CE Technical Files and Supplements for the EU and regulatory submissions for Australia, Canada, Japan, New Zealand and South Africa. Influenced and negotiated regularly with Global Marketing, Corporate Legal, Global Graphics, Quality Assurance, 2 R&D and 5 manufacturing facilities on long-term strategic marketing and development objectives.Monitored current environment developments and presented to key internal stakeholders to assist in decision-making on advertising, promotional and labeling pieces.Participated in notified body and FDA audits as well as competent authority inquiries.Represented Regulatory Affairs department on the Corporate Technical File, Risk Management, CE Benchmarking and TSE Steering Committees.Researched, assessed, and trained Alcon employees at 7 US manufacturing and distribution centers on FDA and International regulations, standards, and publications impacting Alcon’s business worldwide.Created strategic plans for international registration submissions.Prepared registration submissions and supplements for ophthalmic and otic pharmaceutical and medical devices for 30 countries in the Middle East and Africa.Responded to ad hoc queries from global Regulatory Affairs staff.

Gained experience in the dissemination, training, assessment and compliance of SOPs, GLP, GDP, USDA, OSHA and ACUC guidances/regulations and ISO standards.

Maintained existing accounts and cold-called prospective customers in a two state territory.