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Senior Clinical Trial Manager (Homebased)

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AbbVie

8d ago

  • Job
    Full-time
    Mid Level
  • Research & Development
    Healthcare
  • Madrid
  • Quick Apply

AI generated summary

  • You need a Bachelor’s degree, 4+ years in clinical research, knowledge of SOP/ICH/GCP, strong analytical skills, and excellent communication. Global study experience preferred.
  • You will oversee global trials, manage vendors, lead recruitment strategies, ensure inspection readiness, handle study materials, and provide training while supporting submission strategies and process improvements.

Requirements

  • Bachelor’s Degree or OUS equivalent required.
  • Must have at least 4 years of progressive Pharma-related/clinical research-related experience with a high level of core and technical competencies.
  • Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations) and experienced user of systems such as EDC, IRT, CTMS, and eTMF.
  • Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives to actively develop strategies and drive smart decision making to support acceleration of study timelines and enable a well-run study.
  • Excellent organizational and time management skills, strong attention to detail.
  • Exceptional interpersonal skills with ability to communicate effectively in a clear and persuasive manner in a global setting; proficient in business/technical English-language (oral and written).
  • Proactive, collaborative mindset.
  • Ability to work independently in a fast-paced global team environment.
  • Preferred: Exposure to study initiation through completion activities; global study exposure.

Responsibilities

  • Study-level oversight and leadership of one or more global trials in a cross-functional environment for activities from inception through closure, connecting functional work and strategic work across the global study, including but not limited to:
  • Supports the Study Project Manager in strategic leadership of the cross-functional team through stakeholder engagement and influence to drive deliverables and timelines, including strategy development, meeting facilitation, and timely documentation at the study level to drive for timely execution of clinical trial(s).
  • Vendor management, including Request for Proposal (RFP)/initiation, selection, Scope of Work development & review, deliverable oversight, and risk management for one or more external vendors, e.g., central lab, recruitment, imaging, internal and external committees.
  • Recruitment management, including thoughtful review of intelligence data, leadership, cross-functional development, and execution of recruitment strategies and mitigation planning on a global scale from country feasibility through subject recruitment and retention.
  • Leadership of assigned meetings (cross-functional (internal), vendor, and/or investigator) and provision of regular updates on study status, e.g., agenda development, minutes curation and filing
  • Ensure inspection readiness and participate in related activities.
  • Risk identification, mitigation, and management, including timely issue review, escalation, and management to support trend analysis and risk prevention.
  • Co-development and management (review, revision, tracking and filing) of study materials, including but not limited to:
  • Protocols, regulatory submissions, patient reported outcome measures, study execution plan, informed consent, site budgets and agreements, clinical study report, training materials, newsletters, presentations for various stakeholders
  • CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines.
  • EDC, IRT, and ePRO, which includes review of design specifications, participation in user acceptance testing, and contribution to development and review of associated plans and key risk indicators, as well as system management activities like access support, query resolution, and oversight.
  • Management of investigational product and other associated study supplies.
  • Provide engaging training to identified stakeholders as needed, e.g., study team members, vendors.
  • Support global submission strategies.
  • Support process improvement initiatives or serve as a subject matter expert and/or mentor.

FAQs

What is the role of a Senior Clinical Trial Manager at AbbVie?

The Senior Clinical Trial Manager is responsible for the execution of global clinical trials, providing oversight and leadership, and ensuring studies are conducted with quality and efficiency.

What qualifications are required for the Senior Clinical Trial Manager position?

A Bachelor’s Degree or equivalent is required, along with at least 4 years of experience in Pharma-related or clinical research. Competency in standard quality procedures and experience with EDC, IRT, CTMS, and eTMF are also necessary.

What types of trials will the Senior Clinical Trial Manager oversee?

The Senior Clinical Trial Manager will oversee one or more Phase 0-4 clinical trials.

Is vendor management a responsibility of the Senior Clinical Trial Manager?

Yes, vendor management is a key responsibility, including the initiation, selection, and oversight of external vendors.

What skills are essential for this position?

Essential skills include strong analytical and critical thinking abilities, excellent organizational and time management skills, and exceptional interpersonal communication skills.

Will I need to manage recruitment strategies for clinical trials?

Yes, the Senior Clinical Trial Manager will be involved in recruitment management, including the development and execution of strategies for global subject recruitment and retention.

What experience is preferred for candidates applying for this role?

Candidates with exposure to study initiation through completion activities and global study exposure are preferred.

How does AbbVie promote diversity and inclusion in hiring?

AbbVie is committed to hiring qualified individuals without discrimination based on race, color, religion, nationality, age, sex, disability, gender identity, sexual orientation, or marital status.

Will I be working independently or as part of a team?

The role requires the ability to work independently in a fast-paced global team environment while also collaborating with cross-functional teams.

Does this position require ongoing training and support for stakeholders?

Yes, the Senior Clinical Trial Manager is expected to provide engaging training to identified stakeholders such as study team members and vendors as needed.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.