- Ensure projects are conducted in compliance with operating procedures, GCP, ICH, Good Clinical data management practices, FDA regulations, and CDISC and FDA submission standards.
- Ensure compliance with Clinical DM SOPs at the study level.
- Assist the head of data management in establishing standards for electronic Case Report Forms (eCRFs) and edit checks, as well as for any internal tools related to data cleaning such as data listings and reports.
- Lead internal data manager for assigned studies and programs overseeing all data management activities performed by CROs; ensuring major Clinical DM deliverables and milestones are met from study start-up to database lock.
- Participate in the Clinical DM vendor selection and oversight at the study level.
- Facilitate database design according to the protocol, oversee clinical database built by the vendors, and perform and facilitate clinical database user acceptance testing.
- With a thorough understanding of the protocol, review and manage key Clinical DM study documents, such as DM plans, guidelines for CRF completion, data review, SAE reconciliation, Vendor Oversight, TMF plans, and data audits. Ensure Clinical DM Study Documentation is up to date and filed as appropriate.
- Oversee data cleaning and medical coding by vendors by tracking study metrics and performing targeted data reviews.
- Create specifications for internal study team data review plans. Coordinate and lead internal and external clinical data review activities for completeness, accuracy, and consistency in accordance with the data management plan for all studies on an ongoing basis. Consolidate review comments and ensure the resolution of issues identified.
- Represent Clinical DM at study team meetings, provide agenda items, and follow up on action items through resolution.
- Identify and troubleshoot operational obstacles and help drive teams toward a successful resolution of clinical DM issues.
- Drive lessons learned and improvement initiatives internally and with vendors based on metrics, audit reports, and input from study team members and other stakeholders.
- Serves as a Study Clinical DM liaison with cross-functional relevant team members to ensure completion of all timelines and study-related tasks.
- Assist Quality Assurance and the Clinical Study Teams as needed with inspection readiness activities.
- Other duties as assigned.
- In-depth knowledge of FDA regulations, GCP, GCDMP, CDISC, 21CFR Part 11and ICH guidelines
- In-depth knowledge of the clinical trial process, clinical operations, and quality management.
- Knowledge and experience with MedDRA and WHODrug.
- Demonstrated leadership, organizational, project management, and collaboration skills.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Ability to deliver detailed, professional, and quality work products, while working on multiple projects.
- Strong communication (written and oral), decision-making, influencing, and negotiation skills at all organizational levels.
- Successful management of and good working relationships with outside vendors, including CDM CROs
- Must be able to work independently in a fast-paced and collaborative environment.
- Excellent knowledge and skills in the broad technology landscape with strong experience in demonstrating an appropriate balance of business and technical capabilities.
- Technical skills and experience using relational databases (e.g., Medidata Rave, InForm, etc.) and data visualization tools (e.g., Spotfire, J-Review).
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint, Project)
- BS/MS in Life Sciences, Informatics, Computer Sciences, or related fields.
- 8+ years of clinical data management experience in pharmaceutical and/or CRO's
- Complex and international trial experience desired.
- None
- 5% - 10%
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Associate Director, Clinical Data Management - South San Francisco, United States - Structure Therapeutics Inc
Description
Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology.The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs.
We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors.
With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.
POSITION SUMMARY
The Associate Director of Clinical Data Management is an individual contributor and is responsible for planning, implementing, and managing Clinical Data Management (CDM) activities across trials and programs, including but not limited to database and technology selections, vendor management, data collection, and ensuring quality standards are maintained.
The Associate Director, of Data Management assists the head of Data Management with data management activities in support of studies across all stages of clinical drug development.
This role is also responsible for leading initiatives for setting up and enhancing infrastructure for data collection, review, and oversight through company process improvement initiatives, vendor performance assessment, and establishment of clinical data standards.
This position may have direct supervisory responsibilities for internal staff or external consultants. #LI-HybridESSENTIAL DUTIES AND RESPONSIBILITIES
REQUIREMENTS
Education
More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.
Associate Director, Clinical Data Management professionals in South San Francisco
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Kuo-Ching Chang
Data Scientist