Job Description

Job Description

Job Description

About SpringWorks Therapeutics:

SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.

SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.

About the Role:

The Senior Clinical Data Manager I will complete 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.

Location Classification – Hybrid:

This role will be required to work onsite 2 days a week (Tuesday and Wednesday), or more depending on business needs. #LI-Hybrid

Key Responsibilities:

• Designs EDC database (form design and edit check programming) and setup at the protocol level
• Designs and development of eCRFs, CRF completion guidelines, edit checks and data management plans and manages cross-functional review
• Manages UAT for each database build and works with study team to understand the impact of all mid-study updates to the database
• Facilitates and participates in data cleaning, via patient profiles and listings, on an ongoing basis
• Issues queries and provides report trends to the internal teams and CROs
• Ensures the deliverables of external data management vendors are quality, complete and adhere to timelines while also completing reconciliation activities
• May review or complete medical coding
• 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

Qualifications:

• Education: Bachelor's degree in life sciences or related field
• 7+ years Clinical Data Management experience
• Extensive years of combined Data Management/DB build and other clinical experience preferred
• Experience with Medidata Rave (Medidata Architect) and ClinTrak
• Medidata Architect builder proficiency with working knowledge of industry standards, such as CDISC/SDTM
• Basic understanding of SAS, SQL and/or other clinical programming
• Understanding of application of clinical data coding classification systems, e.g., MedDRA, WHO-Drug
• Understanding of steps required to set up and successfully manage delivery of Phase 2-4 studies. Accompanied with strong working knowledge of GCP and ICH guidelines, and Good Clinical DM practices
• Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams' performance.
• Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
• Ability to travel occasionally including overnight stay driven by business need.
• Relocation available.

Compensation:

The expected salary range for this position is $114,330.00 - $150,000.00. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

We offer best-in-class benefits for our team of SpringWorkers who work with urgency on behalf of patients suffering from devastating diseases. Interested in learning more, review additional information here Benefits.

DE&I:
We believe in fostering a culture of belonging. Explore how we are committed to DE&I

EEO Statement:
SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding 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, caste, 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, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks' Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.

This Equal Employment Opportunity Policy applies to all aspects 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.

Privacy:
For more information see our Privacy Policy - Springworks (springworkstx.com)

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