Country Study Start Up 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
The role purpose: The Specialist, Country SSU proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.
Specialists will report into their local country COM but have an operational reporting line to Area and Global SSU Leads.
Primary RESPONSIBILITIES include but not limited to:
Ensuring successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope primarily central IRB/EC sites.
Establishing the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs.
Proactively identifying and communicating issues impacting delivery and providing proposed solutions.
Attending regional/area start up calls and providing input for assigned sites/studies.
Collection of essential documents from sites and completing quality check (ALCOA).
Compiling and submitting ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting.
Coordinating with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements.
Collaborating with contract manager, CRA, Area CSM Lead as required to assure timely site activation.
Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas.
Triggering clinical supply shipments.
Completing IP release activities and triggering IP shipment.
Issuing site green light letter and activating sites in IXRS.
Tracking all start up and maintenance related activities in Vault SSU as appropriate.
Maintaining local country and site intelligence database and EDLs in Vault.
Maintaining SSU performance metrics and KPIs for assigned sites/studies.
Providing start up updates and metrics to CCOM/COM and Area SSU and CSM Leads
Ensuring audit/inspection readiness.
Ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
Participating in process improvement initiatives as required.
Qualifications
Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required.
A minimum of 1-2 years of clinical research experience and preferably 1+ years of study start up management experience for the designated region.
Experience working with remote/virtual teams.
Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives.
Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.
Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment.
Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment.
Very good verbal and written communication in both English and Polish.
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 709 comparable Clinical Development roles across 70 biopharma companies.
Salary context
218 of 709 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 709 comparable roles
+ 30 more countries
Seniority mix
577 of 709 peers have a known seniority level
Therapeutic area mix
154 of 709 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.
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.