The responsibilities of the Manager of Clinical Affairs include, but are not limited to, the following:
1) Familiarity with the conduct of clinical trials and regulatory follow-up;
2) Training of site staff regarding commercial or clinical trials, as well as exam performance and demonstration, as required;
3) Participation in the interpretation and drafting of clinical documents;
4) Clinical examination oversight and assessment of clinical outcomes and interpretation of surgical/clinical results;
5) Sound interpretation of clinical/ocular findings and identification and management of adverse events;
6) Travel to and communication with study sites regarding all study-related issues;
7) Interaction with the company's CRO in managing the clinical database;
8) Participation in review of the clinical database and interpretation of results;
9) Adherence to internal clinical SOP's and international guidelines regarding conduct of clinical studies;
10) Maintenance of clinical files for individual study sites;
11) Ability and willingness to assist with commercial product launch.
Requirements for the position are as follows:
1) Doctor of Optometry degree and active license (required);
2) Experience in medical device industry (highly preferred) and at least 5 years clinical/medical experience, including significant pre and post-op management (required);
3) Previous experience in surgical device trials/FDA-monitored clinical trials (required);
4) Knowledge of FDA Good Clinical Practices guidelines, monitoring and regulatory compliance (preferred);
5) Ability and willingness to travel (40% – 50%);
6) Relocation to Dallas, TX (preferred).
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4651 Woodstock Road
Roswell, GA 30075