The Karyopharm Workplace
Karyopharm Therapeutics, Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department.
Position: Lead Clinical Data Manager
Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
- Work in conjunction with external vendors, CRO(s), to Review/Create (electronic) Case Report Forms and annotated Case Report Forms per Protocol
- Review validation of database structure (DVS), data capture screens, code lists, edit checks, listings and other functions in EDC (e.g. User Acceptance Testing)
- Develop data transfer agreements and specifications with various vendors
- Review eCRF completion guidelines, data management plan (DMP), data validation specifications (DVS, e.g. edit checks), SAE Reconciliation Plan, Data Cleaning Plan and other DM related documentation in conjunction with CRO(s)
- Assist CRO(s) with cleaning data for Interim Analysis, Database lock, and any add hoc requests.
- Liaise with external vendors (Central Labs) in support of timelines and data related deliverables; may also liaise with clinical monitoring in the data management function
- Perform all aspects of Data Management as related to processing and QC of the data, monitor study status, (e.g. Enrollment, eCRFs, Query Aging, etc.) and provide status reports to the team throughout the study
- Responsible for working with database build vendor to develop new EDC databases and subsequent revisions.
- Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports and input from project team members.
- Review and approve study timelines
- Monitor timelines and ensure that clinical data management timeline are met with quality
- Use industry standard conventions, tools, references and process in support of the coding of Medical History, Adverse Events and ConMeds/ConProcs
- Ensures all DM procedures are executed with a high attention to detail, accuracy and timelines
- Review and provide feedback on Protocols, Statistical Analysis Plans and CSRs
- Represent Karyopharm DM on project teams, at Face-to-Face Meetings, Conferences, etc.
- Co-create and review DM SOPs and Work Instructions in accordance with current GCP and ICH guidelines
- Work in conjunction with internal and external Clinical Operations, Research, Clinical Data Management, Pharacovigilence and other operational departments to ensure accurate, efficient, and complete data collection
- Ensure adherence to Data Management standards
- Ability to travel (~travel time 10%, Global Travel)
- Other duties as assigned
- Proficient in Microsoft Office applications (PowerPoint, Microsoft Word, Microsoft Excel, etc.), Internet software, E-mail
- Experience with Electronic Data Capture (EDC) systems
- Experience with reviewing SAS datasets
- Experience with CDISC SDTM/CDASH
- B.S./B.A. in Science related field
- 2 to 5 years of Clinical Data Management experience in the pharmaceutical or biotechnology industry. Minimum 2 years in a Lead CDM capacity
- Highly organized and detail-oriented with effective planning and strong verbal and written communication skills
- Flexibility and agility to adapt to changing scope of work, able to propose thoughtful solutions to challenges and issues, proactively implement solutions, and communicate effectively with colleagues
- Experience/knowledge of GCP and ICH guidelines
Please fill in the Contact Form below to apply for this position