AMVETS Jobs

Description

As part of Clinical Development & Operations (CD&O) team the Site Monitoring Lead Local (SML-l) is a key member of the local Clinical Trial Team assigned to a specific trial(s). Although this role may not be assigned specifically to Oncology, the ideal candidate will still have previous leadership and monitoring experience within Oncology. SML-ls are accountable for ensuring sponsor oversight, trend analysis, signal detection and delivery of their assigned trial(s) in close collaboration with the CRO partner to ensure delivery of BI’s pipeline through accurate planning and efficient execution of Site Monitoring in trials that bring speed & value to participating subjects and sites. This role represents the Monitoring function on US clinical trial teams and direct the efforts of CRAs to monitor US clinical programs effectively and efficiently across multiple therapeutic areas in full compliance with GCP & ICH, quality, safety of patients, data integrity and business goals. The SML-l provides Site Monitoring expertise to and consults the Trial Team, leads and oversees the implementation of the Site Monitoring & Oversight approach and activities as part of overall clinical trial quality management. SML-l contributes to the overall success and delivery of their assigned clinical trial(s)in the R/OPU according to defined milestones and key performance indicators (e.g., Medicine Excellence KPIs -MedEx). The SML-l is accountable for managing the local trial level planning, implementation, issue management, and oversight of the Site Monitoring activities of a trial as assigned, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, BI sponsor obligations, ICH-GCP and applicable regulations and always ensuring inspection readiness.

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 several 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

Trial Preparation:

• Plan trial quality and risk monitoring/ mitigation as part of the Trial Team.

• Deliver Risk-based Site Monitoring approach and training for the trial. Accountable for the development of the operational Site Monitoring & Oversight plans.

• Develop and provide appropriate training of Site Monitoring to Clinical Trial Managers (CT Manager) and Clinical Research Associates (CRA).

• Participate in development of trial level documents.

• Behave as expert and consultant on Site management and monitoring topics.

• Integrate patient/site level feedback to the documents ensuring design with a focus on the patient.

• Participate in and contribute to global/regional and local Trial Team meetings, international/ regional / local Investigator Meetings.

• Timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/Ethics Committee)

• Facilitate communication and direction with CT Managers and CRO CRAs.

Trial Conduct:

• Monitor progress and oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial conduct including adherence to ICH-GCP, and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans.

• Including but not limited to:

• Issue management / oversight on trial level.

• Pre-identification of important protocol deviations from site issues/deviations

• Continuous review, risk identification, evaluation/ analysis and communication on a trial level as applicable.

• Maintain Risk-based Site Monitoring approach for the trial and update Site Monitoring plan and trial level documents.

• Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits) according to plan, implement follow-up actions and escalation, as required.

• Contribute to preparation and implementation of amendments to the trial level documents including training material updates/retraining as needed.

• Facilitate communication and training related to site monitoring in the trial:

• Communication with CT Managers, CRAs, perform re- training etc.

• Participate, prepare input and (co-)lead Trial Oversight Meetings (country and trial level) and contribute to the timely responses to questions from external and internal stakeholders (including Regulatory Authority/ Ethics Committee).

Trial Close-out:

Coordinate timely cleaning and delivery of clinical trial data within OPU

Leadership Competencies:

Creates an environment that inspires, motivates, and empowers colleagues and promotes one common CD&O identity, contributing to acceleration of clinical development timelines and value creation for patients.

Can act as an established Subject Matter Expert A (SME) in the “SME network” locally/globally

Can act as a mentor supervising developing Site Monitoring Leads - Locals (SML-l) at OPU.

Participate in working groups related to site monitoring within the local functional team.

Requirements

• Bachelor’s Degree (Health Sciences, Health Care, Nursing or Others) 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.

• Strong experience within Oncology highly preferred

• 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.

Compensation

This position offers a base salary typically between $111,000 and $183,000.  The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.