This position is responsible for the design, implementation, management of corporate IT infrastructure, IT operations and IT helpdesk, along with execution of IT policies and procedures including testing, change control, and general system maintenance.
he Clinical Trial Manager will be accountable for the day-to-day operational oversight of one or more clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements.
The successful candidate will provide strategic and technical leadership across multiple phases of drug development including but not limited to study design, conduct and analysis; regulatory interactions, publications and clinical development planning.
Lead, draft and oversee the completion of regulatory submission and other key documents (e.g., clinical protocols, investigator brochures, clinical study reports, eCTD/IND clinical and nonclinical summaries, DSURs, orphan annual reports) and Module 1 documents
The Manager of Regulatory Affairs will be responsible for providing regulatory strategy for therapeutic candidates in the metabolic, liver, ophthalmology and oncology therapeutic space, developing regulatory strategies for global development and submissions of therapeutic candidates, planning, coordinating, and authoring of regulatory submissions.
Regularly review existing policies and programs and make recommendations for new plans or changes in existing plans, based on program metrics, company objectives, legislative changes and market trends.