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- Tasks: Lead clinical data management for outsourced trials, ensuring quality and timely data delivery.
- Company: Kailera Therapeutics is dedicated to developing transformative therapies for obesity and related conditions.
- Benefits: Enjoy flexible time off, wellness stipends, and a generous 401(k) match.
- Why this job: Join a passionate team committed to innovation and inclusivity in healthcare.
- Qualifications: 8+ years in clinical data management with strong vendor relationship skills required.
- Other info: This role offers hybrid work options in Waltham, MA or San Diego, CA.
The predicted salary is between 128000 - 160000 £ per year.
Associate Director, Clinical Data Management
Join to apply for the Associate Director, Clinical Data Management role at Kailera Therapeutics
Associate Director, Clinical Data Management
Join to apply for the Associate Director, Clinical Data Management role at Kailera Therapeutics
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
What You’ll Do
The Associate Director, Clinical Data Management plays a key role within the Clinical Development Operations by providing strategic oversight of outsourced clinical trials. This position is responsible for developing and executing project plans for outsourced studies, ensuring vendor activities meet defined quality standards and timelines. As the primary data management representative on the study management team, the Associate Director coordinates ongoing DM activities, partnering closely with key stakeholders to implement a robust and transparent data strategy. They collaborate with CRO, and vendor DM leads to drive timely, high-quality data delivery. This role reports to the Head of Clinical Data Management.
Preferred location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).
Responsibilities
- Provide project-level leadership for clinical data management (CDM) activities, monitor and report on overall study progress
- Develop and maintain study timelines and ensure timely delivery of data-related milestones in collaboration with cross-functional teams and external vendors
- Oversee the creation of study-specific CDM documentation, including eCRF specifications, completion guidelines, edit check specifications, and data management plans—proactively identifying and mitigating risks to data quality and ensuring appropriate filing in the Trial Master File (eTMF)
- Manage CRO CDM counterparts to ensure compliance with scope of work, contractual agreements, timelines, and quality standards
- Conduct end-to-end testing of electronic case report forms (eCRFs), including authoring and executing User Acceptance Test (UAT) plans and scripts prior to deployment
- Develop and execute risk mitigation and action plans as needed to maintain data integrity and operational efficiency
- Actively participate in internal study team discussions and engage with external stakeholders through vendor teleconferences
- Serve as a primary liaison to internal partners (Clinical Operations, Biometrics, Safety/Pharmacovigilance, Regulatory Affairs) and external entities (CROs, third-party data vendors)
- Monitor vendor performance and quality; escalate issues to management and implement corrective actions as appropriate
- Support audit and inspection readiness activities at the study level
Required Qualifications
- At least 8 years of experience in clinical data management, including direct collaboration with CROs and data management vendors; experience in global or cross-cultural environments is preferred
- Comprehensive knowledge of FDA and ICH/GCP regulations and their application to data management processes
- Proficiency in CDISC standards (CDASH/SDTM), medical coding dictionaries, 21 CFR Part 11 compliance, and industry best practices in clinical data management
- Exceptional interpersonal, communication, and organizational abilities, with a demonstrated capacity to manage multiple programs and workflows in a dynamic, team-oriented setting
- Proven success in managing vendor relationships and functional service provider (FSP) partnerships
- Strong track record of building effective relationships and managing expectations with external partners and vendors
- Practical experience with electronic Trial Master File (eTMF) systems related to CDM documentation
Preferred Qualifications
- Experience with regulatory submissions (e.g., IND, NDA/BLA, MAA) and associated data packages
- Familiarity with emerging technologies in clinical data management such as eSource, decentralized trials, and real-time data analytics
Education
- Bachelor’s degree or higher in Life Science or related discipline
Benefits Of Working At Kailera
In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.
- Comprehensive health benefits and tax-advantaged savings accounts
- Flexible time off, 13 paid holidays, and a companywide year-end shutdown
- Monthly wellness stipend
- Generous 401(k) match
- Disability and life insurance
At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.
Salary Range
$160,000—$200,000 USD
Equal Employment Opportunity Information
Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
E-Verify
Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
Seniority level
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Seniority level
Mid-Senior level
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Employment type
Full-time
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Job function
Information Technology
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Associate Director, Clinical Data Management employer: Kailera Therapeutics
Contact Detail:
Kailera Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Clinical Data Management
✨Tip Number 1
Familiarise yourself with the latest trends in clinical data management, especially around eSource and decentralised trials. This knowledge will not only help you stand out but also demonstrate your commitment to staying current in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the industry, particularly those who work at Kailera or similar companies. Engaging in conversations about their experiences can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss your experience with managing vendor relationships and ensuring compliance with quality standards. Be ready to share specific examples that highlight your leadership skills and ability to drive project success.
✨Tip Number 4
Research Kailera Therapeutics' mission and values thoroughly. Understanding their commitment to inclusivity and collaboration will allow you to tailor your discussions and show how your personal values align with theirs.
We think you need these skills to ace Associate Director, Clinical Data Management
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical data management, especially your collaboration with CROs and data management vendors. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: In your cover letter, express your passion for advancing therapies and your commitment to quality data management. Mention specific examples of how you've successfully managed projects or vendor relationships in the past.
Showcase Relevant Skills: Emphasise your knowledge of FDA and ICH/GCP regulations, as well as your proficiency in CDISC standards. Highlight any experience you have with electronic Trial Master File systems and risk mitigation strategies.
Proofread and Edit: Before submitting your application, carefully proofread your documents for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in clinical data management.
How to prepare for a job interview at Kailera Therapeutics
✨Understand the Role
Make sure you thoroughly understand the responsibilities of the Associate Director, Clinical Data Management. Familiarise yourself with clinical data management processes, vendor management, and the specific requirements mentioned in the job description.
✨Showcase Your Experience
Prepare to discuss your past experiences in clinical data management, especially your collaboration with CROs and data vendors. Highlight any successful projects you've led and how you ensured data quality and compliance with regulations.
✨Demonstrate Leadership Skills
As this role involves project-level leadership, be ready to provide examples of how you've effectively managed teams and cross-functional collaborations. Discuss your approach to problem-solving and risk mitigation in previous roles.
✨Ask Insightful Questions
Prepare thoughtful questions about Kailera Therapeutics' culture, their approach to clinical trials, and how they measure success in data management. This shows your genuine interest in the company and the role.
