Site Monitoring Lead - Ridgefield, United States - BI Pharmaceuticals, Inc.

BI Pharmaceuticals, Inc.

Verified Company

Ridgefield, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

Description

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 Riskbased 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.
Preidentification of important protocol deviations from site issues/deviations
Continuous review, risk identification, evaluation/ analysis and communication on a trial level as applicable.
Maintain Riskbased 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 followup 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 onsite monitoring or eight (8) years of relevant business experience in the regulated pharmaceutical or healthcare industry, including onsite 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.