Boehringer Ingelheim
DMPK Clinical Trial Specialist
Boehringer Ingelheim, Ridgefield, Connecticut, us, 06877
Description
The DMPK Clinical Trial Specialist is responsible for clinical trial program support for DMPK, serving as the primary point-of-contact and liaison for DMPK to the clinical trial teams in the role of trial bioanalyst. Additionally, this role is responsible for the logistical coordination and management of outsourced work packages including contracting, monitoring, data transfer and reporting related to clinical sample analysis. 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.
Requirements
Master's degree from an accredited institution with three-plus (3+) years of experience or Bachelor's degree with seven-plus (7+) years’ experience in a scientific discipline and/or project management, or equivalent experience in related field.
Delivering results
Planning and organization
Communication
Quality orientation
Teamwork and collaboration
Customer orientation
Complies with applicable regulations (e.g., FDA GLPs, GCPs), BI standard operating procedures and BI policy
Works in a safe manner.
Duties & Responsibilities
Primary point-of-contact and liaison for DMPK to clinical trial teams, ensuring timely and effective communication of clinical trial information (study related requirements, timelines and issues)
Represent DMPK as a clinical trial team member.
Logistical management of outsourced clinical sample analysis work packages including contracting, processing through Sourcing, PO generation, invoice reconciliation, spend tracking and budget management.
Responsible to key Clinical stakeholders (e.g., TMCP, BDS, CBO and Clinical Operations) for protocol development, sample handling, sample analysis plans, data transfers, reconciliations, milestones, timelines, accurate budgeting and other clinical requirements.
Conducts CRO monitoring of outsourced work packages in support of clinical trial, ensuring critical issues (e.g., technical/scientific, timelines) are communicated to DMPK representatives in a timely manner
Contributes to CRO outsourcing relationship building for successful partnerships
Effectively manage study and data transfer files from CROs to DMPK colleagues and clinical teams
Facilitate data presentation
Manage clinical trial report archival workflows through the Electronic Data Management System (e.g., BIRDS).
May be assigned additional tasks/projects as a primary responsibility under the direction of DMPK Management and/or to support the DMPK Operations team.
Functions as a team member and displays the behaviors and attributes required to complete cross-functional work within a highly dynamic, global work environment, and with external partners, where success depends on effective communication, collaboration and personal accountability.
Onsite/Flex*: This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process.
Compensation Data
This position offers a base salary typically between $111,000.00 and $183,000.00 USD. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards) .
Desired Skills, Experience and Abilities
Scientific background in Drug Metabolism and Pharmacokinetics
CRO management
Experience supporting clinical trials
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.
The DMPK Clinical Trial Specialist is responsible for clinical trial program support for DMPK, serving as the primary point-of-contact and liaison for DMPK to the clinical trial teams in the role of trial bioanalyst. Additionally, this role is responsible for the logistical coordination and management of outsourced work packages including contracting, monitoring, data transfer and reporting related to clinical sample analysis. 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.
Requirements
Master's degree from an accredited institution with three-plus (3+) years of experience or Bachelor's degree with seven-plus (7+) years’ experience in a scientific discipline and/or project management, or equivalent experience in related field.
Delivering results
Planning and organization
Communication
Quality orientation
Teamwork and collaboration
Customer orientation
Complies with applicable regulations (e.g., FDA GLPs, GCPs), BI standard operating procedures and BI policy
Works in a safe manner.
Duties & Responsibilities
Primary point-of-contact and liaison for DMPK to clinical trial teams, ensuring timely and effective communication of clinical trial information (study related requirements, timelines and issues)
Represent DMPK as a clinical trial team member.
Logistical management of outsourced clinical sample analysis work packages including contracting, processing through Sourcing, PO generation, invoice reconciliation, spend tracking and budget management.
Responsible to key Clinical stakeholders (e.g., TMCP, BDS, CBO and Clinical Operations) for protocol development, sample handling, sample analysis plans, data transfers, reconciliations, milestones, timelines, accurate budgeting and other clinical requirements.
Conducts CRO monitoring of outsourced work packages in support of clinical trial, ensuring critical issues (e.g., technical/scientific, timelines) are communicated to DMPK representatives in a timely manner
Contributes to CRO outsourcing relationship building for successful partnerships
Effectively manage study and data transfer files from CROs to DMPK colleagues and clinical teams
Facilitate data presentation
Manage clinical trial report archival workflows through the Electronic Data Management System (e.g., BIRDS).
May be assigned additional tasks/projects as a primary responsibility under the direction of DMPK Management and/or to support the DMPK Operations team.
Functions as a team member and displays the behaviors and attributes required to complete cross-functional work within a highly dynamic, global work environment, and with external partners, where success depends on effective communication, collaboration and personal accountability.
Onsite/Flex*: This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process.
Compensation Data
This position offers a base salary typically between $111,000.00 and $183,000.00 USD. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards) .
Desired Skills, Experience and Abilities
Scientific background in Drug Metabolism and Pharmacokinetics
CRO management
Experience supporting clinical trials
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.