The Sr. Clinical Operations Manager (Sr. COM) 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. Supports Country Head with strategic Country management activities as assigned, including resource, finance / budget, study delivery, TA assignment, and people leadership.
For countries where Sr.COM has overall country responsibility:
Accountable for country clinical trial performance, providing strategic planning, oversight and direction of the country 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.
Responsibilities
- Responsible for the hiring, retention, performance management, mentoring, task assignment, growth, and development of their clinical research team.
- Provide 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 proactively address performance and mitigate risks and issues. 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.
- 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 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.
- Working with the Country COM, may be responsible for resource management of entire country/ies. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie's research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provides solutions. Working with the Country COM, may be responsible for functional budget planning & oversight of expenses across country/ies.
- Supports the Country COM in conducting country feasibility, implementing site selection strategy, and expanding AbbVie's site footprint within the country. Supports the Country COM in driving insightful and impactful interactions with key R&D external stakeholders and agencies.
- May be assigned TA responsibility within an affiliate or lead COM's supporting multiple TA's. Support training and monitoring for the team. Develop and implement strategies to support site and KOL / National leaders identification (including in study feasibility) to support Abbvie pipeline execution within the Country or Region. Work with affiliate teams (including Medical Affairs or Commercial brand teams as appropriate) for assigned TA's.