Sr. Study Management Specialist
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
PURPOSE
Manage and Lead complex and high-priority studies on all aspects of design, planning, startup, conduct, analysis,
reporting and closeout of assigned NIS including regulatory PMOS, IIS and PAA. Responsible for managing planning, timelines, milestone, budget, study sites, vendors and deliverables while maintaining quality and compliance.
CORE JOB RESPONSIBILITIES
Provide comprehensive input to study concept development especially from an operational, feasibility and study execution perspective.
Develop and manage study documentation throughout the study lifecycle, including protocols, protocol amendments, CRFs, informed consent forms and CSRs, and coordinate required reviews, approvals and regulatory submissions, as applicable.
Serve as the operational point of contact for MFDS for regulatory PMOS, including study-related communications and preparation of responses to supplementary requests regarding protocols, annual and final reports.
Lead the end-to-end operational management of assigned studies from concept through final reporting, including study planning, timelines, milestones, issue resolution, stakeholder communication and delivery of study objectives.
Lead study start-up activities and oversee vendor, CRO and study-site selection, set-up and performance to support timely and compliant study execution.
Manage study budgets, forecasting, reconciliation, FMV assessments and investigator payments in accordance with applicable requirements.
Manage PAA operations, including IP supply, importation and destruction; essential document development; applicable reviews, approvals and regulatory filings; and communication with MFDS, HQ, vendors and investigators.
Provide operational oversight of IIS activities, including concept and protocol review, committee approvals, FMV assessments, contracting, milestone tracking, payment management and issue resolution.
Act as a subject matter expert for study management processes including NIS, PMOS, IIS and PAA and Provide guidance and knowledge sharing to study team members.
Contribute to continuous process improvement initiatives to enhance study quality, compliance and operational efficiency.
Assure full compliance with GCP, Global & local SOPs, and Korean regulations
Qualifications
University degree or equivalent; preferably in a medical/science-related field or equivalent work experience in a scientific or health-related field
Minimum 7-year experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 5-years’ direct experience as a project manager. Demonstrated experience independently managing complex studies is preferred.
NIS experience is preferred
Fluent English communication skills (Reading, writing, speaking)
Good understanding of clinical trial processes, AbbVie internal processes and the regulatory environment as well as strong knowledge of clinical research practices, local regulations, and ICH guidelines
Familiarity with AbbVie policies & procedures and local SOPs
Strong computer/technology skills including MS Word, MS Excel and PowerPoint
Fluent English communication skills (Reading, writing, speaking)
Possess strong project management, time management and coordination skills with goodorganizational, leadership, negotiation and interpersonal skills
Strong analytical and problem-solving capabilities with sense of responsibility
Manage conflict, challenges, decision making and risk management as a project manager
Ability to manage time/prioritize, multitask, work independently, self-motivated and follow through with assigned tasks
Excellent written and verbal communication skills demonstrated by the ability to present clear messages from complex information/data to internal/external stakeholders
Additional Information
Code of Conduct & Business Integrity
AbbVie is committed to observe high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers.
AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws.
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 295 comparable Senior Clinical Development roles across 51 biopharma companies.
Salary context
92 of 295 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 295 comparable roles
+ 30 more countries
Seniority mix
295 of 295 peers have a known seniority level
Therapeutic area mix
34 of 295 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.
Open in 2 locations
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
Or follow a whole field: get every new Clinical Development job in South Korea, and choose locations and companies.
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.