JOB DESCRIPTION:

The Opportunity
• Will be required to manage at least one primary project; Depending on scope and phase of project, may support multiple projects.
• Provides project management expertise throughout the development and implementation of clinical studies. Interacts with various study support groups and the business unit in order to assist in clinical strategy, the development of study plans, and project deliverables.
• Is also assigned to other non-trial related activities such as process and procedure teams.
• May support and mentor junior-level project managers.
• Facilitates communication between R&D, Regulatory Affairs, Sales and Marketing, Training, Senior Management and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to mgmt staff.
• Facilitates site selection process by conducting meetings with appropriate departments and individuals to review and revise draft site list as necessary, and by communicating the final site list to team members.
• Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines.
• Identify resource needs and elevates/resolves resource constraints with mgmt.
• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
• Facilitates the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.
• Provides input to protocol design, case report form design, data management plan, monitoring plan.
• Organizes Steering Committee meetings and communication; Coordinates investigator and research coordinator meetings.
• Oversees compliance to study requirements; Reviews compliance to protocol and elevates critical protocol deviations
• Works with Study Team to coordinate activities for all milestones; database locks, annual reports, presentation and publications
• Provides study-specific training to internal team members and site personnel.

Required Qualifications

• Bachelors Degree (± 16 years), Preferably in Life Sciences OR an equivalent combination of education and work experience

• Minimum 5 years, Medical devices, clinical research experience, or related industry. Prefer at least 3 years of related work experience in Quality role in medical device area and/or clinical trial environment. Prefer GCP audit experience.

• Specific requirements: Fluent in English, any additional major language is a preferred asset; Excellent Communicator; Computer Literate.

Preferred Qualifications
• Exercises authority and judgment to determine appropriate action.
• Demonstrates diplomacy and respect for others. Acts as a buffer for the team, providing focus and appropriate prioritization. Facilitates decision making.
• Demonstrates ability to influence others to achieve positive results and collaboration.
• Excellent knowledge of ISO and local regulations and required for clinical trials. Proven record of compliance with, and enforcement of, regulations in clinical trials.
• Sets quality and compliance goals for the trial and monitors/manages compliance as part of clinical project management.
• Develops additional project management tools to improve clinical trial performance.

The base pay for this position is
$90,000.00 - $180,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Clinical Affairs / Statistics

DIVISION:
MD Medical Devices

LOCATION:
United States > Sylmar : 15900 Valley View Court

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
No

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)