Study Start-Up Specialist

NHSHP; New Hampshire; Hybrid; USD 90,000 - 120,000; Full time

Job summary

AbbVie is seeking a Country Study Start-Up Specialist to lead country- and site-level start-up and maintenance activities for assigned clinical trials. You will work with cross-functional teams to support timely site activation while ensuring compliance with regulations and AbbVie policies.

Join a team focused on delivering high-quality start-up deliverables, coordinating ethics submissions, and maintaining essential documents across sites in a hybrid work environment.

Qualifications

• Fluency in Dutch language required.
• Bachelor's degree or equivalent qualification; a health-related degree in medicine, science, nursing, or pharmacy is preferred.

Responsibilities

• Lead start-up and maintenance activities for assigned studies and sites, ensuring timely delivery, quality, and compliance with approved plans.
• Develop country and site activation plans, prioritize activities, and support risk assessment and mitigation with Clinical Operations, Study Start-Up, Contract Management, Clinical Trial Supplies, Regulatory Affairs, and other relevant teams.
• Identify and communicate issues that may affect delivery and recommend solutions.
• Participate in study start-up meetings and provide updates on assigned studies and sites.
• Collect, review, and maintain essential documents in accordance with applicable standards, including ALCOA principles.
• Prepare and submit ethics committee and other local document packages, including informed consent forms, patient materials, and safety documentation.
• Coordinate country submissions, approvals, clinical supplies, and other site activation requirements.
• Collaborate with Contract Managers, Site Monitors, and Clinical Study Management Leads to support timely site activation.
• Review comments on informed consent forms and coordinate required updates and approvals.
• Initiate clinical supply shipments and complete investigational product release activities.
• Issue site green-light letters and activate sites in applicable systems.
• Maintain accurate records in Vault SSU and update country and site intelligence databases and essential document lists.
• Track study and site performance metrics and provide regular updates to relevant stakeholders.
• Support audit and inspection readiness and ensure compliance with AbbVie policies, ICH Good Clinical Practice, and applicable local requirements.
• Contribute to process improvements and support the training and mentoring of new team members.

Skills

Dutch language

Education

Bachelor's degree or equivalent

Job description

ICompany 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

At AbbVie, we discover and deliver innovative medicines and solutions that address complex health challenges and improve people's lives. We are committed to making a meaningful difference for patients and communities worldwide.

As a Country Study Start-Up Specialist, you will lead country- and site-level start-up and maintenance activities for assigned clinical trials. Working with cross-functional teams, you will support timely, high-quality site activation while ensuring compliance with applicable regulations, guidelines, and AbbVie policies.

Key Responsibilities

• Lead start-up and maintenance activities for assigned studies and sites, ensuring timely delivery, quality, and compliance with approved plans.
• Develop country and site activation plans, prioritize activities, and support risk assessment and mitigation with Clinical Operations, Study Start-Up, Contract Management, Clinical Trial Supplies, Regulatory Affairs, and other relevant teams.
• Identify and communicate issues that may affect delivery and recommend solutions.
• Participate in study start-up meetings and provide updates on assigned studies and sites.
• Collect, review, and maintain essential documents in accordance with applicable standards, including ALCOA principles.
• Prepare and submit ethics committee and other local document packages, including informed consent forms, patient materials, and safety documentation.
• Coordinate country submissions, approvals, clinical supplies, and other site activation requirements.
• Collaborate with Contract Managers, Site Monitors, and Clinical Study Management Leads to support timely site activation.
• Review comments on informed consent forms and coordinate required updates and approvals.
• Initiate clinical supply shipments and complete investigational product release activities.
• Issue site green-light letters and activate sites in applicable systems.
• Maintain accurate records in Vault SSU and update country and site intelligence databases and essential document lists.
• Track study and site performance metrics and provide regular updates to relevant stakeholders.
• Support audit and inspection readiness and ensure compliance with AbbVie policies, ICH Good Clinical Practice, and applicable local requirements.
• Contribute to process improvements and support the training and mentoring of new team members.

Qualifications

• Fluency in Dutch language required.
• Bachelor's degree or equivalent qualification; a health-related degree in medicine, science, nursing, or pharmacy is preferred.
• At least 1-2 years of clinical research experience.
• Experience working with remote or virtual teams.
• Working knowledge of ICH Good Clinical Practice and the applicable country's regulatory environment.
• Ability to manage multiple priorities and deliver results in a fast-paced environment.
• Strong analytical, critical-thinking, interpersonal, and communication skills.
• Ability to build trust and work effectively with diverse stakeholders.
• Flexible, adaptable, and proactive approach to problem-solving.
• Experience in clinical trial or study start-up management, particularly within the designated region, is preferred.

Our Culture

At AbbVie, we foster an inclusive and collaborative culture where people are encouraged to bring their authentic selves to work, share ideas, and grow together. You will be part of a supportive team working toward a shared purpose: improving patients' lives.

This role offers a hybrid working arrangement, with flexible hours and the opportunity to work from home. You will typically work from the office 2-3 days per week, depending on your FTE, as part of a great and collaborative team.

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.htmlI