Job Description

Job Description

Job Description

Company Overview:We are a clinical-stage biopharmaceutical organization dedicated to discovering and developing innovative oral therapies for various medical indications with significant unmet needs. Our focus is on targeting biological pathways associated with specific clinical challenges to positively influence disease progression. Our pipeline features multiple programs across diverse therapeutic areas, including those related to pulmonary and fibrotic disorders.

Job Summary:The Director of Clinical Data Management will play a crucial role in supporting Clinical Operations and Biometrics by ensuring the completeness, accuracy, and consistency of clinical data. This position involves overseeing clinical data management activities performed by Contract Research Organizations (CROs), conducting detailed data reviews, and collaborating with cross-functional teams to meet project goals and timelines.

Key Responsibilities:

• Participate in the selection process for CROs involved in data management activities, including proposal reviews and bid defenses.
• Oversee CRO clinical data management activities for assigned clinical studies.
• Manage user permissions and access for all clinical study-related platforms.
• Review and provide feedback on data management and study documentation, including data management plans, study protocols, data transfer agreements, and validation specifications.
• Ensure that case report forms are designed in accordance with study protocols and other relevant documentation.
• Supervise the electronic data capture database build process, including the review of specifications and validation documents. Participate in user acceptance testing of various data systems during initial builds and subsequent updates.
• Conduct thorough reviews of clinical trial data as required.
• Represent the Clinical Data Management function in relevant internal and external meetings.
• Ensure the timely delivery of project milestones and manage CRO performance accordingly.
• Communicate the status of clinical trials, including milestones and deliverables, throughout the study duration.
• Contribute to improvement initiatives within the Clinical Data Management department. Assist in the development and implementation of new technologies and tools. Create standard operating procedures and templates.
• Supervise clinical data management activities and engage in direct negotiations with CROs regarding timelines and quality issues.
• Support clinical data medical reviews.
• Escalate unresolved data or compliance issues to relevant managers and work collaboratively with CRO data managers, partners, vendors, and internal teams to resolve them.
• Assist the Quality Assurance department in conducting audits related to data management activities.

Education and Experience:

• Bachelor’s degree from an accredited institution in a relevant field such as Life Sciences or Computer Science, or equivalent practical experience.
• 10-15+ years of experience in Clinical Data Management within the biopharmaceutical or biotechnology industry, with a strong understanding of clinical drug development processes. Experience with NDA submissions is a plus.
• In-depth knowledge of relevant data management systems and industry standards.
• Detail-oriented, communicative, and accountable, with strong verbal and written communication skills.
• Ability to work collaboratively in a team environment and demonstrate strong interpersonal skills.
• Proven ability to be flexible and manage multiple tasks in a fast-paced, high-pressure setting.
• Experience with CRO and vendor oversight is preferred.
• Strong knowledge of clinical research and relevant regulatory requirements.
• Proficiency in Microsoft Office Suite (Outlook, Word, Excel, etc.).

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