Abbott

Clinical Trial Manager

Abbott • $78K — $156K *
Madison, AL 35758In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in life sciences or related field.
  • 5+ years of clinical research experience.
  • 1+ year leading project teams in study management.
  • Clinical monitoring experience including data review and query resolution.
  • Familiarity with Good Clinical Practices (ICH/GCP) and other regulations.
  • Ability to work in the US without sponsorship.
  • Experience managing external vendors like CROs.

Responsibilities

  • Coordinate and oversee the operational aspects of clinical studies.
  • Prepare and review study-related documents and plans.
  • Develop and manage systems for clinical study execution.
  • Implement tools to monitor study health and timelines.
  • Oversee site management, from recruitment to training and compliance.
  • Lead cross-functional team meetings and maintain effective communication.
  • Manage study budgets and financial forecasting.

Benefits

  • Collaborative and dynamic work environment.
  • Opportunities for continuous professional development.
  • Exposure to diverse and innovative clinical research projects.
  • Potential for involvement in international studies and regulatory submissions.
Full Job Description


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

ADDITIONAL LOCATIONS:

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)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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