Clinical Operations Manager
About this opportunity
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Job Description
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 other’s 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Job details
How this role compares
Computed from every other active Clinical Development role in our database, not just this employer's listings.
We currently track 433 comparable Manager Clinical Development roles across 67 biopharma companies.
Salary context
135 of 433 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 433 comparable roles
+ 33 more countries
Seniority mix
433 of 433 peers have a known seniority level
Therapeutic area mix
36 of 433 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.