IQVIA Associate Director, Safety Management, (Home Based) - IQVIA Biotech in Boston, Massachusetts
IQVIA Biotech is seeking an Associate Director, Safety Management (home-based) and must have clinical experience:
Supports the department Director in the management and oversight of all aspects of Safety Management Department staff and services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project specific procedures.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Provides support to the department director with all aspects of the Safety Management department including projects and staff. Key responsibilities include:
Oversight and review of existing as well as development of new department policies and procedures
Responsible for the successful planning, allocation and forecasting of staff resources for the completion of client projects. Establish project resource contingency plans for key resources within the Safety Management Department.
Advise on problem resolution, such as deviations from project plans
Supervise and manage the daily activities of members of the Safety Management Department. Ensure staff adherence to professional standards and standard operating procedures established for the Safety Management Department across all projects.
Build a team environment among department staff and between other functional units
Provides support with departmental training, mentoring, coaching, performance management and career development. This includes:
Ensuring that existing and new staff are fully trained on adverse experience reporting and database processes
Ensuring training records for staff are complete
Establish, maintain and revise quality performance metrics to ensure continuous improvement in the areas of productivity and quality.
Provides support to the development of annual department budgets, FTE projections, and short- and long-range departmental goals and objectives.
Provides input and assists Business Development in all safety related issues required for the preparation of proposals/ contracts for potential sponsors. This involves scope of work and budget development, and participation in teleconferences, meetings and presentations.
Serves as a departmental resource regarding the interpretation and application of FDA and international regulations regarding adverse event reporting. Maintains current knowledge of industry and regulatory agency trends in adverse event handling, reporting, and investigation.
Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties. Champions and implements new company initiatives in terms of process improvement or new technology related to clinical research.
Demonstrates honesty and integrity in dealing with others. Work effectively with different types of people. Accepts constructive feedback without becoming defensive.
Seeks input from others when faced with a difficult situation. Makes sound decisions within the scope of responsibility. Focuses on resolving problems.
Establishes and maintains effective relationships with customers (clients and site personnel) and gain their trust and respect. Provides customers with complete and accurate information. Maintains a high energy level when interacting with customers. Acts with the customer in mind.
Performs other related duties as assigned or requested by the department Director.
KNOWLEDGE, SKILLS AND ABILITIES:
In depth knowledge of clinical research process and medical terminology.
Broad based expertise in clinical trial safety.
Excellent written and verbal communication skills. Able to effectively express complex ideas.
Positive attitude and ability to interact effectively with all levels of staff to successfully direct Safety Management department activities and staff.
In depth knowledge of issues/considerations involved with collecting safety data in an electronic data capture environment.
In depth knowledge of current ICH/GCP guidelines applicable to the conduct of clinical research.
Excellent organizational and interpersonal skills.
Ability to reason independently and effectively problem solve complex issues.
Excellent attention to detail.
Demonstrates excellence in customer service and professionalism.
Identifies personal career development goals and opportunities related to current job. Solicits and applies performance feedback.
Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.
Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.
Independently prioritizes time effectively based on department needs. Consistently meets deadlines.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Ability to travel domestically and internationally
Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required.
Advanced degree preferred.
Minimum of 7 years of experience in clinical trial safety.
Must have a demonstrated history of strong leadership skills including a minimum of 3 years of supervisory experience.
Equivalent combination of relevant education and experience.
Computer literacy and experience working with Microsoft Office (Word, Excel) required
Knowledge of electronic data capture preferred.
Excellent verbal and written communication skills required.
Excellent interpersonal and organizational skills required.
Ability to work independently, prioritize effectively and work in a matrix team environment required.
Ability and willingness to travel domestically and internationally as required; ability to rent automobile.
This position is classified as exempt from the Fair Labor Standards Act; employees are not eligible for overtime compensation.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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