Senior Clinical Data Manager

Allucent is a comprehensive contract research and development organization with international resources devoted to assisting pharmaceutical and biotechnology firms navigate the regulatory approval process quickly and efficiently; with the aim of introducing new drugs, biologics, and medical devices to those who need them. Allucent is a non-laboratory based setting.

The Senior Clinical Data Manager I (CDM I) leads and organizes Data Management (DM) outcomes ranging from database design & setup, through cleaning and reporting to database lock, ensuring that the thoroughness, precision and consistency of clinical data meets the quality standards and regulatory mandates for analysis and reporting.

This role also offers leadership and expertise in relevant data management fields and cross-functional initiatives, including the development of departmental processes, tools, and staff training.

The Senior CDM I is a part of the Data Management staff.

Requirements

Data Management

• Function as the primary contact for DM with all relevant internal (e.g. Project Management, Clinical Monitoring, Biostatistics and other functional groups) and external parties (e.g. sponsors, external vendors, investigational sites).
• Project and plan the resources needed including management of tasks, timelines, risk, and quality.
• Track budget, forecasts and manage changes of scope requests.
• Participate in the review of study documents (e.g. protocol, (electronic) case report forms (eCRFs), safety plans/manuals and statistical analysis plan).
• 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 throughout the project lifecycle and ensure adherence to project requirements.
• Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks.
• Generate training materials for EDC users and provide project-specific training as needed.
• Review and validate clinical data to ensure consistency, accuracy, integrity and completeness.
• Formulate a 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.
• Conduct and/or coordinate various data transfers and reconciliation actions including (but not limited to) SAE, PK, and (other) external laboratory data.
• Execute medical coding tasks as required.
• Participate in conference calls and/or meetings with vendors and sponsors.
• Manage the database implementation, lock and close-out processes and procedures.
• Maintain documentation on an ongoing basis and ensure all filing is up to date.
• Plan and create necessary documentation to support internal and external audits; participate in such audits.
• Provide leadership, expertise and support to other department members.
• Identify and resolve potential issues and evaluate effectiveness.

Learning & Development

• Actively support staff learning & development.
• Develop and deliver applicable DM departmental training.
• Participate in the hiring process for new employees.
• Train and mentor data management staff.
• Proactively track data management development trends and updates, in consultation with department Global Head and/or Directors, for further alignment and improvement of current processes.

Quality Management

• Contribute as a Subject Matter Expert (SME) in the field of CDM activities to the evaluation/improvement and standardization of processes and procedures within the Quality Management System.

Account Management, Sales & Acquisition

Assist in preparing new proposals.

Contribute and take part in client evaluations, visits and bid defense meetings.

Others

• Contribute to other areas of business as required.

Benefits

Qualifications

• Degree in life science, healthcare and/or related field.
• A minimum of 5-10 years of relevant work experience.
• A minimum of 5-10 years of experience in drug development and/or clinical research.
• Basic knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (local) regulatory requirements.
• Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation).
• Experience in CDISC conventions, i.e., CDASH, SDTM model and hands-on experience implementing these models.

Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies.

Skills

Proficient with various computer applications such as Word, Excel, and PowerPoint required.

Strong written and verbal communication skills including good command of English language.

Presents well, outgoing and client-focused.

Ability to work in a fast-paced challenging environment of a growing company.

Administrative excellence.

• Strong project management skills.
• Attention to detail, strong technical, analytical and problem-solving skills.
• Ability to simplify complex matters into understandable concepts.

Ability to convert guidelines, rules, and regulations into clear and usable recommendations.