Notes : Candidate needs to be an individual or an independent contributor. Candidates from a complete CRO and FSP background are eligible.
The Senior Clinical Data Manager (CDM) leads and coordinates 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.
This position also serves to contribute to process improvements, staff learning & development and provides input for DM services cost proposal.
The Senior CDM is a member of the Data Management staff.
Responsibilities :
Serve as primary contact for DM with all relevant parties both internally (e.g., Project Management, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.
g. sponsors, external vendors, investigational sites) on a regular basis throughout the study
- 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 throughout the lifecycle of the project and ensure adherence to the project requirements.
- Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks.
- Create training materials for EDC users and provide project-specific training as required.
- Review and validate clinical data to ensure consistency, accuracy, integrity and completeness.
- 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 reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data.
- Perform Medical Dictionary for Regulatory Activities (MedDRA) and / or World Health Organization Drug Dictionary (WHO-DD) medical coding procedures
- Participate in conference calls and / or meetings with vendors and sponsors.
- Keep track on project timelines and manage changes of scope, budgets and resourcing needs.
- Keep oversight on relevant Data Management activities within a project, as specified in the Data Management Plan
- Manage the database implementation, lock and close-out processes and procedures.
- Organize and distribute study data to facilitate statistical analysis and reporting.
- Maintain documentation on an ongoing basis and ensure that all filing is up to date.
- Plan and create necessary documentation to support internal and external audits; participates in such audits
- Provide leadership, guidance and support to other department members.
Qualifications :
- B.S. degree in life science, healthcare and / or related field
- Basic knowledge of ICH-GCP(R2), GDPR / HIPPA and applicable (local) regulatory requirements
- Experience with tools and systems for managing clinical studies.
- 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.
- Eye for detail, strong technical, analytical and problem-solving skills
- Ability to simplify complex issues into understandable concepts.
Principal - Clinical Data & Technology
Strategy, Clinical Execution, Data Sciences and Technology to empower client organizations achieve their passion for patient care, science and business success. This role will have responsibility to drive growth in our Clinical Technology business by taking ownership of one or more client accounts t...
Principal Clinical Trial Manager
Principal Clinical Trial Manager. Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Mas...
Clinical Data Manager
Must have 8 or more years of clinical data management experience in biotech / pharma industry with significant hands-on end-to-end experience in clinical data management practices. Review CRFs to ensure alignment with protocol; lead and perform sponsor acceptance testing of the eCRF; and ensure data...
Senior Clinical Data Manager
The Senior Clinical Data Manager will represent Clinical Operations Data Management on the CTT, and with partners and/or Data. As the Senior Clinical Data Manager, you will be operationally responsible for tasks within the planning, start-up, conduct and closure of clinical trials from final synopsi...
Senior Clinical Data Manager
To train others to make full and correct use of the company Data Capture systems, when used, for the collection of clinical data. To ensure that adequate QC checks (including spot checks) and Database Quality Assessments on the clinical databases of assigned projects. To manage each of the data mana...
Senior Clinical Data Manager (Hybrid or Remote)
The Senior Clinical Data Manager will be part of the cross-functional trial specific CTT and be responsible for core deliverables such as clinical database design/setup, data collection, data validation, manual review, and timelines. The Senior Clinical Data Manager will represent Clinical Operation...
Senior Manager, Clinical Data Management
Clinical Data Management key focus is to ensure data quality, integrity & completeness of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database Lock. This role may report into Director, Clinical Data Management or Associate Director, Clinical Data Managemen...
Senior Clinical Data Manager
To train others to make full and correct use of the company Data Capture systems, when used, for the collection of clinical data. To ensure that adequate QC checks (including spot checks) and Database Quality Assessments on the clinical databases of assigned projects. To manage each of the data mana...
(Senior) Manager, External Data Acquisition, Clinical Data Management
Manager in External Data Acquisition, you will play a pivotal role within our Clinical Data Management team. Standardize data type specifications to align with Electronic Data Capture (EDC) requirements and clinical trial. Coordinate with vendors to guarantee that data collection is compatible with ...
Clinical Data Manager
Must have or more years of clinical data management experience in biotech / pharma industry with significant hands-on end-to-end experience in clinical data management practices. Review CRFs to ensure alignment with protocol; lead and perform sponsor acceptance testing of the eCRF; and ensure databa...