1. Reads and analyzes protocol, statistical analysis plan, CRF and other trial design documents and discusses with other team members such with as biostatisticians and data managers.
2. Develops and debugs simple to complex SAS program in a timely manner
3. Implements statistical analysis plan, data preparation, and data manipulation into SAS programs and macros
4. Create analysis datasets, statistical tables, figures, and listing for clinical trial data.
5. Create CDISC standard datasets (SDTM and ADaM)
6. Participates in the validation of SAS programs and analysis datasets
7. Maintains documentation for SAS programs and validation results
8. Leads and coordinates the programming work for projects involving SAS programming if necessary
9. Coordinates timelines in orders to fulfill the needs of other departments
1. Design CRF based on study protocol and prepare the CRF completion guideline.
2. Generate data management plan and data validation plan.
3. Clinical Data Management / Clinical data management status report.
4. Provide training to the site personnel and reporting agencies on proper data collection processes.
5. Coordinate with clinical monitoring activities to help provide prompt feedback to sites on data quality.
6. Establish data quality standards and works with reporting agencies to ensure standards are met.
7. Generate and close queries or apply self evident corrections to the data according to the relevant guidelines.
1. SAS programming for tables, figures and listing.
2. Protocol and synopsis design with statistical methodologies.
3. Project support / Statistical analysis.
4. Sample size estimation and power analysis.
5. Statistical analysis report/plan writing.
6. Communicate with client regarding to statistical issues.
1. Draft, review, and finalize clinical study documents in compliance with ICHGCP,
applicable regulatory guidelines, and sponsor specifications, including
but not limited to:
▪️Clinical study protocols and protocol amendments
▪️Investigator’s brochures (IB) and IB updates
▪️Clinical study reports
▪️Informed consent forms
▪️Briefing documents for regulatory meetings
▪️Patient narratives and safety summaries
▪️Clinical sections of regulatory submissions (e.g., CTD Module 2.5, 2.7)
2.Ensure scientific accuracy, clarity, and consistency of content across all
documents
3.Collaborate cross-functionally with biostatistics, data management, clinical
operations, medical affairs, pharmacovigilance, and regulatory affairs teams
Interpret statistical and clinical data for integration into reports and summaries
4.Follow internal SOPs, writing style guides, and client-specific templates or
standards
5.Maintain awareness of current regulatory requirements and industry best
practices in clinical documentation
6.Assist in developing and maintaining document timelines, ensuring timely
delivery
7.Respond to quality control or medical/scientific review comments and
incorporate revisions accordingly
8.Hold PI meetings, and present protocols and clinical trial results to PIs and
relevant personnel
9.Undertake other MA-related tasks as assigned by the line manager
- Manage the execution of the assigned clinical project(s) per service contract from
initiation through closeout, ensuring that all clinical project -and project
deliverables are completed with the Sponsor’s satisfaction and ensure quality
deliverables on time and within budget and in accordance with SOPs, policies and
procedures.
- Manage and coordinate the efforts of cross-functional project teams to support
milestone achievement; manage study issues and obstacles within the agreed
timeline.
- Develop project management plans, study tools and training materials as required,
lead team assignments and accountabilities, oversight of central file maintenance.
- Serve as primary project contact with Sponsor to ensure communication is
maintained and reporting schedules are adhered to.
- Serve as liaisons between sponsors, investigational sites and project operational
team to achieve the deliverables with quality.
- Collect information on team performance against contract, customer expectations,
or project baselines. Lead problem solving and resolution efforts, including
management of risk, contingencies and issues.
- Identify quality issues and escalate the findings within the project appropriately;
implement corrective action plans through appropriate parties.
- As assigned, provide input on proposal development for new business and
participate in the bid-defense process under supervision.
- Tracks and reports the progress of assigned clinical trials including timelines,
subject enrollment target and budget adhere to the contract.
- Preparation, oversight and review of project related documents within the
regulated timeline.
- Supervise clinical team members and assess their performance of project deliveries
through daily clinical operations, provide input to line manager of project team
members to identify the training needs.
- Prepare and present project information at internal and external meetings.
- Scheduling co-monitoring/accompanied site visits with CRA to ensure quality of
study conduction at site through efficient monitoring.
- Lead audit and inspection preparation, participation and follow-up
- Perform other duties as assigned