Clinical Trial Manager

Abbott; Madison (WI); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott in Madison, WI is seeking a Clinical Trial Manager to support or lead the management, planning, execution, and closure of clinical studies. The CTM collaborates cross-functionally to oversee day-to-day operations and ensure successful execution of Abbott’s clinical research plans.

This role may be based in Madison, WI or San Diego, CA and requires a life sciences degree, 5+ years in clinical research, and strong vendor oversight.

Qualifications

• Bachelor’s degree in life sciences or related field as required for essential duties.
• 5+ years of experience in clinical research.
• 1+ year leading project teams through start-up, conduct, data management, analysis, close-out and report writing of clinical studies.
• Clinical monitoring experience including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, maintenance and closeout visits.
• Experience writing, reviewing and editing protocols.
• Knowledge of Good Clinical Practices (ICH/GCP), ISO 20916 and applicable regulations governing clinical research.
• Authorization to work in the US without sponsorship.
• Ability to perform essential duties with or without accommodation.
• Experience overseeing external vendors (CROs, central labs, call centers, DCT providers).

Responsibilities

• Coordinate and oversee operational aspects of a study including planning, start-up, enrollment and close out activities.
• Prepare, review and implement study plans and documents including timelines, protocols, ICFs, recruitment plans, monitoring plans, budgets, site contracts and budgets, vendor plans.
• Develop systems and materials to support efficient execution of clinical studies and manage during conduct.
• Develop, implement and maintain tools to monitor study health, timelines and finances for management and stakeholders.
• Participate in study database development and CRF design, guideline development, edit checks and UAT.
• Oversee sample management activities including planning, handling, shipping, processing and results.
• Develop site recruitment plans and monitor site performance.
• Forecast and manage study expenses; oversee site contracting and budget management, invoicing, accruals and budget tracking.
• Oversee training, data entry, TMF maintenance and ensure compliance with study plans.
• Conduct monitoring activities as needed.
• Ensure closure of studies through data verification, database lock planning, site readiness and report development.
• Identify, qualify and manage vendors for study support.
• Provide guidance to team members and foster knowledge sharing.
• Lead cross-functional meetings and interact with investigators, sites, vendors and consultants.
• Travel up to 20% as required.

Skills

Clinical trial management

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in life sciences

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

The Opportunity

The Clinical Trial Manager (CTM) is responsible for supporting or leading the management, planning, execution, and closure of clinical studies. The CTM works collaboratively and cross-functionally in an exciting, fast paced environment to oversee the day-to-day operations of assigned clinical studies and ensure the successful execution of the company’s clinical research plans.

This position may be in Madison, WI or San Diego, CA.

What You'll Work On

Include, but are not limited to, the following:

• Coordinate and oversee the operational aspects of a study including planning, start-up, enrollment and close out activities ensuring that deliverables are completed on time, within budget, and in compliance with department procedures, applicable regulations and quality standards.
• Prepare, review and implement study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, study budgets, site contracts & budgets, vendor management plans and other essential clinical study documents.
• Develop plans for systems and materials required to support the efficient execution of clinical studies and is responsible for effective management during the conduct of the study.
• Develop, implement and maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances to department management and other stakeholders.
• Participate in study database development by reviewing and contributing to case report form (CRF) design, CRF completion guideline development, edit check & manual data review requirements, and participation in user acceptance testing (UAT).
• Oversee sample management activities including planning, sample handling, kit supply management, sample shipping, processing, and resulting.
• Develop site recruitment plans and is responsible for the identification, selection, start-up and performance monitoring of clinical research sites.
• Develop study budgets and is responsible for accurately forecasting and managing study expenses. Oversee site contracting and study budget management including facilitation of site contract and budget negotiations, invoice review and approval, accrual management and maintenance of budget tracking tools.
• Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance, and ensure compliance with study plans such as the study protocol, monitoring plans, and recruitment plans.
• Conduct monitoring activities as needed.
• Ensure the smooth and efficient closure of studies through development of plans for completion of data verification & review, planning & facilitation of database lock activities, determination of site & IRB/EC readiness for closure, statistical analysis and clinical study report development.
• Participate in the identification, qualification, selection and management of vendors providing support to clinical studies.
• Provide oversight and support for assigned clinical operations study team members. Leads cross-functional team meetings, ensuring study goals and priorities are clear. Professionally interacts with investigators and site staff, vendors, key opinion leaders and consultants.
• Ability to identify, mitigate and manage study risks. Responsible for maintaining ongoing study audit readiness and participates in internal or regulatory authority audits.
• Provide guidance and support to less experienced team members. Fosters a collaborative and knowledge-sharing environment, promoting continuous learning within the team.
• Ability to provide oversight to multiple studies.
• Participate or may facilitate department or project initiatives under the direction of department management or lead clinical trial manager.
• Uphold company mission and values through accountability, innovation, integrity, quality and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work a designated schedule.
• Ability to work on a mobile device, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to work on a computer and phone simultaneously.
• Ability to travel 20% of working time away from work location, may include overnight/weekend travel.
• Ability to attend off-site meetings and conferences as needed.

Required Qualifications

• Bachelor’s degree in the life sciences or field as outlined in the essential duties.
• 5+ years of experience in clinical research.
• 1+ year of experience of experience leading project teams through the start-up, study conduct, data management, analysis, close out and report writing of clinical studies.
• Clinical monitoring experience including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, site maintenance, and site closeout visits.
• Experience writing, reviewing and editing protocols.
• Knowledge of applicable quality standards (e.g. Good Clinical Practices (ICH/GCP), ISO 20916) and applicable local and national regulations governing clinical research.
• Authorization to work in the US without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Experience providing oversight to external vendors (e.g. CRO, central labs, call centers, DCT providers).

Preferred Qualifications

• 1+ year of clinical research experience with a sponsor company or CRO.
• International study experience, IVDR, and GDPR implementation.
• Working knowledge of the FDA submission process including, IDE, PMA and 510(k).
• Experience as a study coordinator or clinical research associate.
• Sample management system experience.

The base pay for this position is

$78,000.00 - $156,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

ONCO Cancer Diagnostics

LOCATION:

United States > Madison : 5505 Endeavor Ln

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf