AnaptysBio Inc
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Description:
The Associate Director, Clinical Data Management will be responsible for supporting data management activities in phase 1 – 4 clinical trials. The incumbent will oversee outsourced studies ensuring appropriate interpretation and translation of the study protocol into validated data collection applications, tools, and systems (EDC, eCOA, IWRS), cleaning and validation of the data, and delivery of fit for use data for analyses. In addition to study/CRO oversight the Associate Director will partner with management and cross functional teams to identify, execute, and support continuous process improvement initiatives, creating both tactical and strategic solutions that support the mission to deliver treatments of autoimmune and inflammatory diseases. The individual must have working knowledge of regulatory guidelines, project management principles, risk assessment/management and problem solving skills. Communication, both written and verbal are critical success factors in managing the expectations and delivery of/to the cross functional study teams, the CROs executing the study, and management. This position reports to the Director of Clinical Data Management.
- Partner with CROs to drive data management deliverables; set expectations, monitor progress, resolve issues and meet study timelines
- Contribute to the creation of RFPs and review vendor proposals, budgets, scope of work and change controls.
- Participate in Clinical Protocol review to ensure data requirements are clearly identified, purpose driven and accessible via validated data collection methods
- Accountable for all start-up, conduct and closeout activities associated with clinical data management activities
- Ensure all data management documentation is created, reviewed, implemented and archived (TMF) including but not limited to the Data Management Plan, Data Transfer Agreements, Coding Conventions, eCRF Completion Guidelines, SAE Reconciliation, Data Validation Specifications, etc.
- Following CDISC conventions, oversees or performs eCRF design, database development, eCRF annotations and SDTM data sets
- Review / Develop database (DB) specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations
- Proficient in creating and executing UAT Plans for data collection modules, data validation checks and programming deliverables as required
- Create data continuity mappings of all EDC and non-EDC data flows; from collection to reporting, identifying all dependencies, handoffs and cycle times associated with each step in the process
- Participate in cross-functional Clinical Study Team meetings as the representative of data management. Providing insight into the planning, conduct and execution of the clinical study by providing actionable metrics, identified risks and ongoing achievements
- Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
- Participates in the preparation and presentation of data, when applicable.
- Interface with Statistical Lead and programming to provide key data for periodic reporting (e.g. DSMB, IB update, DSUR, IND Annual Update)
- Familiar with Risk Based Monitoring and the role Data Management / Biostats can play in focusing monitoring resources
- Utilize project management principles and apply them both upstream and downstream to assure study deliverables are accomplished according to plan
- Assist in formulating short-term solutions and long-term strategies to improve Data Management efficiencies. Support a culture of continuous process improvement by finding solutions to inefficient or ineffective processes
- Perform other related duties as required and assigned (i.e., support audits/inspections)
Supervisory Responsibilities
None Requirements:
Education & Experience:
- Theoretical knowledge typically achieved through a related four-year college experience, such as a Bachelor's degree in science or a related field.
- 10 years of progressive DM experience in pharma or biotech industry with a minimum of three years managing CRO data deliverables
- Broad experience to work effectively in a small company
Knowledge and Competencies:
- Demonstrated leadership in a cross-functional team setting
- Experience in a hands-on early development role within a small organization is a plus.
- Demonstrated ability to handle a high volume of highly complex tasks within a given timeline
- Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize
- Effective communication and interpersonal skills
- Ability to work effectively in as a team player in a complex, changing environment, intensely committed to success and getting the job done well.
- Self-motivated, independent, and results-oriented
- Excellent organizational and problem-solving skills with the capacity to organize assignments and work within deadlines
- Highly attentive to details
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
Work Environment
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
May be required to travel by plane or car.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
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