Clinical Trial Manager

Abbott•Madison, WI

7d•Hybrid

About The Position

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.

Requirements

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).

Nice To Haves

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.

Responsibilities

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.