Clinical Operation Manager

Main Areas of Responsibilities

• Manage day-to-day monitoring activities on assigned study to ensure deliverables are met by tracking and maintaining project metrics and status of deliverables. Proactively communicate and escalate issues risks and staffing needs to Program Lead RSMs and Clinical Trial Team.
• Act as a resource for RSMs to answer study questions and provide guidance as Allergan standard study process experts.
• Review completed Site Feasibility Questionnaires Site Qualification Visit reports and maintains all tracking reports (SIV IMV RMV COV) for assigned trial.
• Develop monitoring documents and toolkits for trial to ensure consistency such as Protocol Specific Monitoring Plan and amendments report annotation visit checklists tool kits etc. Provide PSMP training and assist with conducting GSMO orientation sessions as necessary.
• Conduct with RSM teleconferences to deliver training and information as required. Attend team meetings and disseminate information as necessary.
• Collaborate with CTT and GSMO PL in review of study specific eCRFs completion guidelines protocol deviation specifications user acceptance testing etc.
• Serve as Risk Based Monitoring (RBM) ambassador ensuring implementation and adherence to RBM requirements on trial.
• Maintain monitoring portion of study portal.
• Maintain knowledge of ICH/GCP regulatory requirements Allergan SOPs therapeutic area (protocol amendments).
• Site presence (may be responsible for monitoring 1 sites on assigned trial or co-monitoring/oversight visits etc.)
• Principal LSM additional tasks: mentoring new LSMs assisting with LSM orientation training sessions contribute to process development improvement and documents to drive consistency.  Principal LSMs will typically be assigned to more complex therapeutic areas.

Qualifications :

Qualifications

• Allied Health Professions degree (PA RN RPh) relevant clinical experience or four-year life science degree.
• Minimum 5 years monitoring experience in a pharmaceutical or medical device company or clinical research organization.
• More than 5 year of industry experience.
• Prefer candidates that have functioned as a lead monitor/ have equivalent experience.

Skills

Advanced skills in Microsoft Word Microsoft PowerPoint Microsoft Excel Microsoft OneNote

Must possess excellent skill/ability in the following:

• Written and oral communication
• Planning Organizing Metrics Tracking
• Controlling Directing and Promoting Innovation
• Decision Making Judgment and Problem Solving
• People Relationships Influencing Others Motivating Employees Team Building Developing People
• Initiative and Accountability
• Assigning work reviewing work and Planning others work
• Maintaining activities and Coordinating activities
• Training RSMs on trial specifics

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:

Work :

Yes

Employment Type :

Full-time