Senior Clinical Data Manager I

Allucent is a comprehensive contract research and development body with international resources committed to aiding pharmaceutical and biotechnology companies streamline and expedite the regulatory approval process. This way, we ensure the swift delivery of novel drugs, biologics, and medical devices to those who need them. Allucent operates in a non-laboratory environment.

The Senior Clinical Data Manager I (CDM I) spearheads and organizes Data Management (DM) deliverables ranging from database design & set-up to cleaning and reporting up to database locking. The position guarantees the thoroughness, precision, and coherence of clinical data align with the quality standards and regulatory prerequisites for analysis and reporting.

This role additionally offers leadership and expertise in pertinent data management sectors and cross-functional initiatives, encompassing the evolution of departmental processes, tools, and staff training.

The Senior CDM I is part of the Data Management team.

Key Responsibilities

Data Management

• Act as the main DM point of contact with all applicable parties internally (e.g., Project Management, Clinical Monitoring, Biostatistics, other functional groups) and externally (e.g., sponsors, external vendors, investigational sites).
• Forecast and allocate required resources, managing tasks, timelines, risk and quality.
• Scrutinize budget, forecasts and manage changes of scope requests.
• Engage in reviewing study documents (like protocols, (electronic) case report forms (eCRFs), safety plans/manuals, and statistical analysis plan).
• Aid in clinical study database set-up, including eCRF design and database validation requirements.
• Formulate, review and maintain project-specific DM documents comprising data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements during the project lifecycle and ensure sticking to project requirements.
• Coordinate and perform the database User Acceptance Testing (UAT) related tasks.
• Develop training materials for EDC users and give project-specific training as needed.
• Assess and validate clinical data for consistency, accuracy, integrity, and completeness.
• Prepare a data cleaning plan in consultation with relevant functional groups and oversee data releases (like DETC/DSMB/IDMC, interim and final locks, updates after lock).
• Generate project metric reports, status updates, study progress, feedback and advice on site performance issues, data trends and protocol non-compliance etc.
• Liaise and carry out various data transfer and reconciliation activities encompassing (but not limited to) SAE, PK, and external laboratory data.
• Complete medical coding tasks as necessary.
• Participate in conference calls and/or meetings with vendors and sponsors.
• Oversee the database implementation, lock and close-out processes and procedures.
• Maintain documentation constantly and ensure up-to-date filing.
• Plan and prepare required documentation to support internal and external audits; engage in these audits.
• Lend leadership, expertise and support to other department members.
• Anticipate and resolve potential problems and appraise efficacy.

Learning & Development

• Actively encourage staff learning & development.
• Create and conduct applicable DM departmental training.
• Take part in the interview process for new recruits.
• Train and mentor data management staff.
• Proactively observe data management development trends and updates, in consultation with department Global Head and/or Directors, for aligning and enhancing current processes.

Quality Management

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

Requirements

Qualifications

• Degree in life science, healthcare and/or related field.
• Minimum 5-10 years of relevant work experience.
• Minimum 5-10 years of experience in drug development and/or clinical research.
• Basic knowledge of ICH-GCP(R2), GDPR/HIPPA and fitting (local) regulatory requirements.
• Sound understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation).
• Experience in CDISC conventions, such as CDASH, SDTM model and practical experience implementing these models.
• Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies.
• Ability to translate guidelines, rules and regulations into clear and usable recommendations.

Skills

• Proficiency in diverse computer applications such as Word, Excel, and PowerPoint.
• Strong written and verbal communication skills along with a good grasp of the English language.
• Outgoing and client-centric behavior.
• Capacity to work in a fast-paced challenging environment of a growing company.
• Administrative excellence.
• Robust project management skills.
• Detail-oriented, strong technical, analytical and problem-solving skills.
• Ability to simplify complex issues into understandable concepts.

Benefits

• Extensive benefits package.
• Competitive salaries per location.
• Departmental Study/Training Budget for enhancing professional development.
• Flexible Working hours (within reason).
• Potential for remote working.
• Improved work-life balance.
• Internal growth opportunities and career progression.
• More task variety.
• Financially rewarding internal employee referral program.
• Access to online soft-skills and technical training via GoodHabitz and internal platforms.