Manager, Site Monitoring - Ridgefield, CT location - Onsite
Represent the Clinical Research Associate (CRA) function on US clinical trial teams and direct the efforts of CRAs to effectively and efficiently monitor US clinical programs across multiple therapeutic areas in full compliance with GCP & ICH, quality, safety of patients, data integrity and business goals.
Serve as the Site Monitoring Lead (SML) – US for assigned trials.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
- Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~ 5-7) across Therapeutic Area(s), including:
- Coordinate & provide trial-specific training.
- Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs (>20) working on assigned trials.
- Monitor clinical monitoring deliverables for assigned trials in clinical operations system(s) (e.g. BICTMS)
- Review of Trial Monitoring Manuals, as requested
- Responsible for the progress of monitoring activities, including CRA capacities, for assigned trials in accordance with timelines and budget, including on-time submission of deliverables (e.g., site monitoring visit reports, follow-up letters, etc.).
- Work with CRAs to report compliance issues with their sites, as appropriate, and support the development and execution of corrective action plans.
- Partner with CO Training & Compliance Group, Quality Medicine, and cross-functional partners to address monitoring compliance issues.
- Review internal audit report observations and support CRAs to develop a plan for addressing actions.
- Perform skills assessments for CRA candidates, as requested.
- Serve as Site Monitoring Lead (SML). Responsible for providing operational expertise to the trial team on the site monitoring approach for the trial. This includes but is not limited to developing the Trial Level Monitoring Manual and provide related input into trial plans and processes. Deliver the site monitoring oversight plan for the trial and develop and provide trial specific training for the CRAs globally. Oversee the monitoring activities in the trial including issue management oversight and pre-identifying important protocol deviations. Perform risk indicator review to support pro-active risk mitigation. Conduct process and site quality performance monitoring by overseeing and performing site monitoring visits (remote and in-person).
- Serve as a SML associate (SML-a) which is a subset of the above accountabilities.
- Serve as a SML-US who help support the site monitoring oversight visits for their assigned trials.
- Assist with in-house Site Monitoring inspection readiness activities and lead preparations for site regulatory inspections, as requested.
- Ensure quality and compliance in support of regulatory applications and accountable for successful regulatory inspection.
- Represent site monitoring on local/global working groups.
- Support continuous improvement strategies within site monitoring.
- Work with CO Training & Compliance Group to deliver training programs (e.g., onboarding)for field monitoring staff.
- Identify ways to streamline work processes and support quality improvement initiatives.
- Promote customer-centric behaviors with all external site facing resources to enhance BI’s reputation.
- Adherence to all relevant SOPs, regulatory policies and BI policies and procedures.
- Bachelor’s Degree from an accredited institution (Health Sciences, Health Care, Nursing or Others) is required with a minimum of five (5) years of experience performing on-site monitoring or eight (8) years of relevant business experience in the regulated pharmaceutical or healthcare industry, including on-site monitoring experience.
- CRA Manager experience, preferred.
- Demonstrated experience in the regulated pharmaceutical or healthcare industry.
- Thorough understanding of all phases of drug development (I-IV).
- Understanding of federal regulations pertaining to IND and NDA regulations.
- Experience leading and managing teams.
- Ability to travel overnight domestically and/or internationally, as needed.
- Communication; fosters an environment that encourages open, honest communication enabling teams to make effective decisions and achieve results
- Customer focused; Drives customer centric culture in all site facing-interactions
- Problem solving; avoids escalation and develops quality compliant solutions to monitoring issues that arise in support of BIPI portfolio
- Quality focused; ensures field monitoring practices are consistent with BI QMS and drives cost savings Influencer; uses collaborative data driven approach to communicate site monitoring needs & constraints
- Innovative; consistently seeks out the industry best practices to provide superior site monitoring results
- Faster decision-making: Focus more on decision logic, less on consensus of all parties. Limit alignment to the needed degree. Keep external focus at the center.
- Flexibility: Be open for changes. Anticipate and adapt quickly to rapidly developing trends and market conditions.
- Down- (vs. upward) delegation: Actively take decisions in your area of accountability. Involve your leader in case of issues or when it is needed due to, e.g., risk; empower those on your team rather than micro-manage.
- Ownership: Be responsible for the key topics in your area (incl. cross-functional) and make sure that they develop as expected (I treat the company as my own and take responsibility for results).
- Outcome-based thinking: Focus on the desired outcomes and work backward toward the means to achieve them (rather than process orientation).
- Clear and concise approach: Identify and choose logical alternatives based on a systematic analysis and classification of options.
- Results-orientation: Take responsibility for solving problems and focus on effective solutions (consider novel approaches) and their fast realization (80:20 rule).
- Smart risk-taking: Stretch outside the comfort zone by taking controlled, acceptable risks. Take the lead in achieving challenging goals. Encourage/empower those on your team.
- Innovativeness: Lead the industry in better ways of serving the customers and drive new, more effective ways of working.
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required)
- Must be 18 years of age or older
Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC, and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable law.