SR MGR CLIN RESEARCH

SR MGR CLIN RESEARCH

Milpitas, CA

EXP 7-10 yrs

DEG Bach

RELO

BONUS

TRAVEL

Job Description.

Primary Job Function:

This position has full responsibility and authority to carry out job duties as Sr. Mgr, Clinical Research. This position directs, develops and implements the worldwide clinical investigational plans for projects related to AMO product portfolios consistent with corporate objectives. Studies done by this department must be in compliance with appropriate international guidelines and regulatory agencies. Supervises, develops and trains clinical research personnel in the conduct of clinical trials.

Core Job Responsibilities:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Develops the overall strategy for the worldwide clinical investigational plan.

Responsible for directing the implementation through completion of clinical studies, from the early phases of product development and protocol design to investigator selection, monitoring, data collection, analysis, interpretation and final report writing, Accountable for the overall summary of safety effectiveness for registration packages. Responsible for development and management of study budgets and personnel resources required to conduct clinical studies.

Responsible for maintaining Good Clinical Research Practices and SOPs in compliance with ISO/ANSI, FDA and other regulatory guidelines. Manages a team that may include Managers Principal CRA; Plans, develops, and manages clinical studies on new or existing products, ensuring that such studies are ethical, scientifically valid, and legally acceptable in order to meet both corporate and regulatory requirements and is responsible for the completion and approval of all contractual agreements involving field investigators.

Plans for and manages a constant flow of activities directed toward project completion and coordinates monitoring system based on study schedules to ensure effective and efficient study completion. Includes coordination of activities with Clinical Operations and Biostatistics and Data Management.

Manages a team that may include Principal Clinical Research Associates, Senior Clinical Research Associates, Clinical Research Associates, and Clinical Research Assistants; hires, trains, and motivates personnel to meet departmental needs; schedules appropriate training sessions; and coaches career development.

Evaluates and interprets clinical research data to ensure timely and accurate data analysis of completion of interim and final reports and scientific presentation of study data in a way that fairly and accurately reflects study results.

Prepares Global Clinical Research Plans with associated budgeting and personnel requirements and assures that assigned projects operate within budget.

Participates in appropriate in-house meetings to represent the department and remain abreast of

Developments relating to current and planned clinical programs.

Supervisory / Management Responsibilities:

Indirectly oversees and supervises up to 40 investigational sites including investigators and their staff

Position Accountability / Scope:

Reports to the Director of Clinical Research

1. Provides technical consultations to other department for registration purposes, acquisitions, marketing, and sales training.

2. Prepares and manages annual budget for Clinical Research department.

3. Represents Medical Optics as an expert in directing Clinical Research programs to outside companies, regulatory agencies, professional societies to assure a high level of communication and to present image as a research-oriented company.

4. Hires, trains, and ensures retention of high-caliber individuals in the Clinical Research organization.

5. Interacts with FDA and other worldwide regulatory agencies to assure studies achieve product approval

Minimum Education:

BA/BS or equivalent years of experience required. Advanced degree (MS, Ph.D., M.D., O.D., or Pham.D preferred).

Minimum Experience / Training Required:

8-10 years of directly related experience in clinical research planning and execution required, preferably in the field of ophthalmology with high level of expertise in the areas of statistics, study design, ocular and systemic pathology, ocular and systemic pharmacology and ophthalmic optics. Additionally, must have strong supervisorial skills and ability to interact with all levels of the organization. Also, be able to interact with physicians at a peer level