Logo of Huzzle

Clinical Operations Manager (REMOTE - EAST COAST)

image

AbbVie

14d ago

  • Job
    Full-time
    Mid Level
  • Research & Development
    Healthcare
  • Florida City
    Remote

AI generated summary

  • You need a health-related Bachelor's, 3 years of monitoring experience, strong communication and organizational skills, mentoring abilities, and a focus on innovation and integrity.
  • You will lead a clinical research team, manage performance, ensure GCP compliance, oversee audits, handle budget/resource management, and drive strategic initiatives for pipeline delivery.

Requirements

  • Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
  • Monitoring Experience: Minimum 3 years.
  • Excellent interpersonal skills with the ability to communicate persuasively with clarity, collaboratively, and cross functionally. Demonstrates flexibility to changing requirements with the ability to establish and leverage relationships and trusted partnerships. Demonstrated proactive and positive team player.
  • Exhibits strong planning and organizational skills. Experience across multiple therapeutic areas and study phases.
  • Mentoring and coaching skills. Has the ability to provide transparent and timely feedback to raise the bar on individual and team performance.
  • Drives innovation and continuous process improvement.
  • Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
  • Deals comfortably with risk and ambiguity, changing course when needed.
  • Ability to make timely, high-quality decisions based on available data and information.
  • Ability to work independently and take initiative/ownership. Ability to adapt and move quickly.

Responsibilities

  • Responsible for the hiring, retention, performance management, mentoring, task assignment, growth, and development of their clinical research team.
  • Provides leadership and oversight to the clinical research team including, but not limited to: performs accompanied visits (on-site and off-site); accelerates AbbVie's priority programs through close collaboration with internal and external stakeholders; conducts trend analysis and gap assessments to proactively identify training and developmental opportunities for assigned personnel; addresses gaps effectively to help assigned personnel achieve country and site level KPIs and metrics.
  • Utilizes AbbVie systems and tools to support assigned personnel to proactively address performance and mitigate risks. Proactively identifies individual needs of their team members, removes obstacles, proposes solutions, and tailors support to enable successful, on-time monitoring and / or delivery of their assigned study activities.
  • Ensures adherence to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.
  • Supports, trains, and oversees assigned personnel to ensure that they maintain audit and inspection readiness at assigned sites/studies. Prepare and follow up on site and country audits, CAPA preparation and implementation.
  • Accountable for resource management for assigned team, as follows: Utilizes reports from available systems and country/area model to accomplish; In alignment with AbbVie research goals, priorities, an specific study timelines; Ensure resource utilization to address business priorities and maximize team impact to delivery of the pipeline.
  • Accountable for the budget management and payments of the assigned studies conducted by their assigned team, as applicable. Creates an inclusive environment to enable team members to reach their full potential. Helps team connect strategy to execution and promotes collaboration with stakeholders to effectively deliver pipeline.
  • Leads and supports the team to understand the business strategy and vision. Drives and implements change through effective communication and management.
  • May participate and/or lead global/local task forces and initiatives. Responsible for activities as assigned by Line Manager. Proactively identifies opportunities at local/ global levels and proposes solutions to create efficiencies and streamline/improve processes. Partners with research sites with high levels of coordinated and impactful site engagement with KOLs, National Leads, Principal Investigators and site staff positioning AbbVie as the partner of choice in clinical trials.
  • May be assigned TA responsibility within an affiliate. Support training and Monitoring for team, develop and implement strategies to support Site and key opinion / National leader identification (including feasibility) to support AbbVie pipeline execution within the Country or Region. Work with affiliate teams (including Medical Affairs and Commercial brand teams where appropriate) for assigned TA's.
  • this is a Remote East Coast position

FAQs

What is the job title for this position?

The job title is Clinical Operations Manager.

Is this position remote?

Yes, this position is remote for candidates located on the East Coast.

What are the key responsibilities of the Clinical Operations Manager?

The key responsibilities include building and leading clinical research teams, ensuring clinical trial performance, strategic planning, team member development, resource and budget management, ensuring compliance with regulations, and fostering partnerships with internal and external stakeholders.

What qualifications are required for this role?

A Bachelor's degree or equivalent in a health-related field is preferred, along with a minimum of 3 years of monitoring experience.

What skills are essential for success in this role?

Essential skills include excellent interpersonal communication, strong planning and organizational skills, mentoring and coaching abilities, adaptability to change, and the ability to make data-driven decisions.

Does the role involve budget management?

Yes, the Clinical Operations Manager is accountable for budget management and payments related to the assigned studies conducted by their team.

Are there opportunities for professional development in this position?

Yes, the role emphasizes mentorship, growth, and development of team members, ensuring they achieve key performance indicators and metrics.

Is AbbVie an equal opportunity employer?

Yes, AbbVie is committed to equal opportunity employment and embraces diversity and inclusion.

Will the Clinical Operations Manager participate in audits?

Yes, this role includes supporting and preparing for audits and ensuring inspection readiness at assigned sites/studies.

What kind of benefits does AbbVie offer?

AbbVie offers a comprehensive benefits package, including paid time off, medical/dental/vision insurance, and a 401(k) plan for eligible employees.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.