Clinical Data Manager II

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

Summary:

The Clinical Data Manager II (CDM) leads and coordinates the successful delivery of Data Management (DM) deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.

The CDM II is a member of Data Management staff.

Location: Cary, NC - Hybrid preferred

Responsibilities:

• Participate in the review of study documents (e.g. protocol, (electronic) case report forms (eCRFs), safety plans/manuals and statistical analysis plan)
• Provide support on clinical study database set-up, including eCRF design and database validation requirements.
• Develop, review and maintain project-specific DM documents including data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements
• Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks
• Assist in reviewing and validating clinical data to ensure consistency, accuracy, integrity and completeness
• Assist in create data cleaning plan in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
• Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance etc.
• Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
• Assist in medical coding tasks as assigned

• Participate in conference calls and/or meetings with vendors and sponsors
• Recognize and solve potential problems and evaluate effectiveness
• Support and manage the database implementation, lock and close-out processes and procedures
• Maintain documentation on an ongoing basis and ensure that all filing is up to date
• Support planning and creating necessary documentation to support internal and external audits; participates in such audits assigned
• Help to align data management and clinical programming best practices, standards and conventions within the company

• Actively support staff learning & development within the company wherever appropriate.
• Participate in applicable DM departmental meetings
• Train and mentor less experienced data management staffs as appropriate.
• Assist in proactively tracking data management development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes.

Requirements

• Life science, healthcare and/or related field
• Minimum 3-6 years of relevant work experience
• Minimum 3-6 years of experience in drug development and/or clinical research
• Basic knowledge of ICH-GCP(R2), GDPR/HIPAA and applicable (local) regulatory requirements
• Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation)
• Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models
• Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required
• Strong written and verbal communication skills including good command of English language
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging envir