Provide and maintain oversight and guidance related to site monitoring activities throughout the course of a trial, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, ICH-GCP and applicable regulations and ensure inspection readiness at all times.
Provide operational expertise to the trial team on the site monitoring approach for the trial. Oversee the implementation of the site monitoring approach. The function holder may develop expertise and capabilities as a Site Monitoring Lead (SML) guided by a mentor (experienced SML) and/or for trials with small scope (i.e. limited geographical spread) and low complexity which are conducted in accordance with the BI standard processes and procedures.
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:
Deliver site monitoring approach for the trial:
Develop Trial Level Monitoring Manual and provide related input into trial plans, processes (e.g. trial risk assessment, Trial ISF/TMF, IMP management, Supplier selection such as central imaging or laboratory) and documentation (e.g. input into CTP, IQRMP, IC and develop SFQ and other relevant site logs/forms such as source data status report, etc.).
Deliver site monitoring oversight plan for the trial:
Develop Site monitoring oversight plan and provide related input into trial level supplier oversight plan.
Ensure appropriate training:
Provide input into trial training plan and develop and deliver trial-specific training for Clinical Research Associates (CRAs).
Support streamlined data collection:
Provide input into eCRF
Support development of checklists/templates (as appropriate) and support IRT set-up (input into IRT requirements/set-up and conduct UAT)
Participate as appropriate in trial team meetings, International/regional investigator meetings and Drug supply meetings
Facilitate communication with Clinical Trial Managers (CTMs) and CRAs.
Oversee site monitoring activities in the trial:
Issue management / oversight on trial level: review and assess site issues, escalate to CTL as appropriate, prepare for trial oversight/MQR meetings and follow up on further actions with countries
Pre-identify important protocol deviations from site issues/deviations for CTL (and TSTAT) to take final decision.
Pro-active risk mitigation: perform regular risk indicator review as applicable and determine and follow up on required actions
Maintain site monitoring approach for the trial and update Trial Level Monitoring Manual, site monitoring oversight plan and other core trial documents such as ISF templates etc. as required
Conduct process and site quality performance monitoring and checkpoint calls with the CRAs in a trial according to the site monitoring oversight plan, implement follow-up actions and escalation as required
Facilitate communication and training related to site monitoring in the trial:
Communication with CTMs, CRAs, perform re-training etc.
Participate, prepare input and (co-)lead trial oversight meetings
Coordinate DBL planning with Trial Team and countries.
Support compilation and review of the quality section for the clinical trial report for site monitoring activities.
Facilitate communication with CTMs and CRAs
Adhere to international, local and internal requirements in the planning, conduct and reporting of clinical trials.
Support the development of company relationships with opinion leaders and set up good working relationship with investigational site staff, internal staff, Vendors.
Participate in working groups related to site monitoring.
Ensures all tasks are carried out in accordance with respective applicable BI Standard Operating Procedures (SOPs), BI processes and regulatory requirements. Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BI values.
Bachelor's Degree (Health Sciences, Health Care, Nursing or Others) from an accredited institution required with a minimum of 8 years of relevant business experience in the regulated pharmaceutical or healthcare industry.
On-site monitoring experience is required.
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. required.
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.
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Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, 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 law.