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About SpringWorks Therapeutics
SpringWorks Therapeutics is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing, and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand its portfolio.
About the Role:
The Clinical Data Manager will assist in all activities for the global clinical study data management process from start-up to database lock and regulatory submission support. This individual will aid in ensuring clean and valid clinical study data is delivered to biostatistics, through the EDC build, programming of edit checks, cleaning and performing all data management activities for the life-cycle of a study. This position will help coordinate activities with CROs, other external vendors, database programming and trial operations to define and implement data management requirements.
Responsibilities:
- Assist with EDC database design (form design and edit check programming) and setup at the protocol level
- May work closely with CROs during the design and development of eCRFs, CRF completion guidelines, edit checks and data management plans
- Participates in UAT for each database build and work with vendor to understand the impact of all mid-study updates to the database
- Participates in data cleaning, via patient profiles and listings, on an ongoing basis
- May issue queries and provide report trends to the internal teams and CROs
- Assists in ensuring the deliverables of external data management vendors are quality, complete and adhere to timelines
- Participates in reconciliation activities between the safety and clinical database on ongoing basis
- Creates data management plans and documentation as applicable
- Perform other duties and responsibilities as assigned
About You:
Education:
- Bachelors Degree in Life Science or related field.
Experience:
- 2+ years Clinical Data Management experience
- 3 years of combined Data Management and other clinical experience preferred
- Experience with Medidata Rave
Skills:
Technical:
- Working knowledge of industry standards, such as CDISC/SDTM
- Basic understanding of SAS, SQL and/or other clinical programming
- Basic understanding of application of clinical data coding classification systems, e.g., MedDRA, WHO-Drug
- Good working knowledge of GCP and ICH guidelines, and Good Clinical DM practices
- Solid computer/analytical skills
- Proficient in Microsoft Word, Excel and PowerPoint
Communication:
- Excellent written and verbal communication
- Must be able to interact and liaison effectively with people at all levels of the organization and with external vendors, investigators, site personnel, etc.
Other:
- Detail-oriented and well organized
- Understanding of steps required to set up and successfully manage delivery of Phase 2-4 studies
The expected salary range for this position is $85,000 – $113,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Are you a SpringWorker?
How much do you care?
How well do you partner with others?
How fast do you move?
Are you a problem solver?
Are you comfortable challenging convention?
At SpringWorks Therapeutics, we ignite the power of promising science to unleash new possibilities for patients. We work hard, we care even harder and we’re in it together. We are looking for ambitious, smart, and hardworking colleagues to join our growing team.
SpringWorks is an equal employment opportunity employer that is strongly committed to equal employment opportunities for all individuals. The Company does not discriminate in employment opportunities or practices on the basis of actual or perceived sex (including pregnancy, childbirth, breast feeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, domestic violence victim status, sex offense or stalking victim status, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws.
This Equal Employment Opportunity Policy applies toallaspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.
GDPR Statement: When you apply to a job on this site, the personal data contained in your application will be collected by SpringWorks Therapeutics (“Controller”), which is located at 100 Washington Blvd, Stamford CT 6902 and can be contacted by emailing . Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under the standard contractual clauses. You can obtain a copy of the standard contractual clauses by contacting us at [email protected].
Your personal data will be retained by Controller for as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.
