Clinical Operations Manager

AbbVie

15h

About The Position

The Clinical Operations Manager manages day-to-day monitoring activities for assigned studies, ensuring deliverables are met by tracking project metrics and deliverable status. The role proactively communicates and escalates issues, risks, and staffing needs to the Program Lead, RSMs, and Clinical Trial Team, and serves as a resource for RSMs by answering study questions and providing guidance on Allergan standard study processes. The position reviews completed Site Feasibility Questionnaires and Site Qualification Visit reports and maintains trial tracking reports for SIV, IMV, RMV, and COV. It develops monitoring documents and toolkits, including Protocol Specific Monitoring Plans and amendments, report annotations, and visit checklists; provides PSMP training; and may assist with GSMO orientation sessions. The role also conducts teleconferences with RSMs to provide training and information, attends team meetings, and disseminates information. The Clinical Operations Manager collaborates with the CTT and GSMO PL on study-specific eCRFs, completion guidelines, protocol deviation specifications, and user acceptance testing. It serves as a Risk Based Monitoring ambassador, supporting implementation and adherence to RBM requirements, and maintains the monitoring portion of the study portal. The role requires maintaining knowledge of ICH/GCP, regulatory requirements, Allergan SOPs, and the therapeutic area, including protocols and amendments. Site presence may include monitoring one site on an assigned trial or conducting co-monitoring or oversight visits. Additional tasks for Principal LSMs include mentoring new LSMs, assisting with LSM orientation training, contributing to process development and improvement, and developing documents that promote consistency. Principal LSMs are typically assigned to more complex therapeutic areas.

Requirements

Allied Health Professions degree (PA, RN, or RPh), relevant clinical experience, or a four-year life science degree.
Minimum of 5 years of monitoring experience in a pharmaceutical or medical device company or clinical research organization.
More than 5 years of industry experience.
Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, and Microsoft OneNote.
Excellent written and oral communication skills.
Skills in planning, organizing, metrics tracking, controlling, directing, and promoting innovation.
Decision-making, judgment, and problem-solving skills.
Ability to build relationships, influence others, motivate employees, build teams, and develop people.
Initiative and accountability.
Ability to assign work, review work, and plan others’ work.
Ability to maintain and coordinate activities.
Ability to train RSMs on trial specifics.

Nice To Haves

Experience functioning as a lead monitor or equivalent experience.
For Principal LSM assignments, experience or suitability for more complex therapeutic areas.

Responsibilities

Manage day-to-day monitoring activities on assigned studies and track project metrics and deliverable status.
Communicate and escalate issues, risks, and staffing needs to the Program Lead, RSMs, and Clinical Trial Team.
Answer study questions and guide RSMs on Allergan standard study processes.
Review completed Site Feasibility Questionnaires and Site Qualification Visit reports.
Maintain tracking reports for SIV, IMV, RMV, and COV.
Develop monitoring documents and trial toolkits, including Protocol Specific Monitoring Plans and amendments, report annotations, and visit checklists.
Provide PSMP training and assist with GSMO orientation sessions as needed.
Conduct teleconferences with RSMs to deliver training and information as required.
Attend team meetings and disseminate information as necessary.
Collaborate with the CTT and GSMO PL on study-specific eCRFs, completion guidelines, protocol deviation specifications, and user acceptance testing.
Promote and support implementation of and adherence to Risk Based Monitoring requirements on assigned trials.
Maintain the monitoring portion of the study portal.
Maintain knowledge of ICH/GCP, regulatory requirements, Allergan SOPs, and the relevant therapeutic area, protocols, and amendments.
Provide site presence, potentially including monitoring one site on an assigned trial or conducting co-monitoring or oversight visits.
For Principal LSMs: mentor new LSMs, assist with LSM orientation training, contribute to process development and improvement, and develop documents to drive consistency.