Clinical Operations Manager
Clinical Operations Manager
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Job Description
Purpose: To advance AbbVies pipeline by striving for excellence in clinical research turning science into medicine for our patients and leveraging new capabilities to drive industry leading performance.
This role is accountable for building and leading high performing clinical research teams who partner with investigative sites for meaningful and effective engagements striving to position AbbVie as the partner of choice in clinical trials.
Accountable for teams clinical trial performance providing strategic planning oversight and direction of the team to ensure on time within budget and quality delivery of clinical studies.
Establish partnership with internal stakeholders to drive insightful and impactful interactions and promote the value of the clinical research team through the contribution to the R&D portfolio success.
Reports to: Country Clinical Operations Head
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 AbbVies 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 TAs.
Qualifications :
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.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
