Senior-Clinical-Trial-Associate

2+ years

$76.500,00---$127.500,00

Remote, USA

10 Aug. 16, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Clinical Trial Associate (CTA)

Company: Genmab

About Genmab:

At Genmab, we are dedicated to building extraordinary futures by developing innovative antibody therapies that transform cancer treatment and other serious diseases. Our mission is to create impactful therapies that change patients' lives. With a commitment to science and a passion for innovation, we strive to be uniquely determined and authentically driven in everything we do.

Role Overview:

As a Senior Clinical Trial Associate (CTA) at Genmab, you will play a crucial role in managing the eTMF (electronic Trial Master File) and supporting key administrative activities within the Global Clinical Trial Management (GCTM) team. Your responsibilities will include ensuring trial-level inspection readiness, coordinating meetings, managing communications, and supporting clinical study documentation and governance.

Key Responsibilities:

eTMF Management:
- Set up, maintain, and close Sponsor eTMF including trial, country, sites, and EDL (Essential Document List).
- Oversee eTMF activities, including monthly reviews and spot checks.
- Prepare for audits and inspections.
Meeting and Communication Management:
- Coordinate logistics for Clinical Trial Team (CTT) meetings, including invitations, recording, and filing.
- Write meeting minutes and manage oversight dashboard (ODB) review meetings.
- Provide updates on Clinical Trial Governance (CT Gov.) site status.
Planning and Resource Management:
- Maintain staff and vendor lists in GenTrack/GenSense.
- Set up and manage CTT Charters.
- Support the CTM in reviewing TMD and Portfolio App in GenSense.
- Contribute to Trial Oversight and TMF Plans.
Clinical Study Report (CSR) Management:
- Assist with filing appendices of Clinical Study Reports (CSR).

Competencies:

Strong planning, organization, and multitasking abilities.
Experience in clinical development and process orientation.
Excellent communication skills, both oral and written.
Effective problem-solving, critical thinking, and adaptability.
Collaborative teamwork and vendor/stakeholder management.
Ability to maintain audit readiness and focus on quality.

Qualifications:

Experience with complex trials, preferably pivotal or phase III trials.
Subject Matter Expert (SME) in CTA processes.
Proven ability to work in a dynamic, fast-growing environment.
Experience or strong desire to work in a rapidly evolving company.

Salary Information:

For US-based candidates, the salary range for this position is $76,500 - $127,500. The actual offer will be based on various factors, including skills, qualifications, experience, and location. Additional compensation such as bonuses may also be offered.

About You:

Passionate about our mission to revolutionize cancer treatment.
Committed to excellence and a science-driven approach.
A collaborative team player with a drive to innovate.
Comfortable working in a fast-paced, dynamic environment.
Enjoys working hard while having fun.

Locations:

Genmab supports an agile working environment to enhance work-life balance. Our offices are open, community-focused spaces designed to foster connection and innovation. We also offer remote working options.

Company Overview:

Established in 1999 and headquartered in Copenhagen, Denmark, Genmab is a leading biotechnology company with a focus on developing next-generation antibody therapeutics. We have a robust pipeline and strategic partnerships aimed at transforming patient care through innovative therapies.

Diversity and Inclusion:

Genmab is committed to diversity, equity, and inclusion at all levels of the company. We ensure equal opportunities and fair treatment for all applicants, regardless of race, color, religion, sex, national origin, age, disability, or genetic information.

Application Privacy:

We are dedicated to protecting your personal data. Please review our Job Applicant Privacy Notice on our website for details on how we handle your information.

Note: In the Netherlands, Genmab’s policy for permanent hires is to initially offer a fixed-term contract for one year. Renewal for an indefinite term may be considered based on performance and business conditions.

Apply Now:

Ready to make a difference? Join us in transforming lives with innovative therapies. Apply today or connect with our Talent Network to stay updated on future opportunities.

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Senior-Clinical-Trial-Associate

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