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 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.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
•Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies. Competency in 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 identify and communicate issues impacting delivery and providing proposed solutions.
"Attend regional/area start up calls and providei input for assigned sites/studies. Collection of essential documents from sites and completing quality check (ALCOA).
•Compile and submit ethics and other required local document packages including customization of ICFs, patient facing materials and safety reporting. "
"Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements.
•Collaborate with contract manager, Site Monitor, 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. "
Trigger clinical supply shipments. Complete IP release activities and triggering IP shipment. Issue site green light letter and activating sites in IXRS. Track all start up and maintenance related activities in Vault SSU as appropriate.
"•Maintain local country and site intelligence database and EDLs in Vault.
•Maintain SSU performance metrics and KPIs for assigned sites/studies. Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads. Ensure audit/inspection readiness. "
•Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
•Participate in process improvement initiatives as required.
•Train and mentor new Specialists, Country Start Up
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 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.
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 Research role in our database, not just this employer's listings.
We currently track 102 comparable Clinical Research roles across 18 biopharma companies.
Salary context
28 of 102 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 102 comparable roles
+ 20 more countries
Seniority mix
64 of 102 peers have a known seniority level
Therapeutic area mix
10 of 102 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.