Senior Clinical Data Manager I

4 weeks ago

Durham, United States SpringWorks Therapeutics Full time
Job DescriptionJob 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)

  • Senior Clinical Data Manager

    1 week ago

    Durham, North Carolina, United States Duke University Full time

    About the RoleWe are seeking a highly skilled Senior Clinical Data Manager to join our team at Duke University. As a key member of our clinical research team, you will be responsible for ensuring the quality and accuracy of data in various studies. Your expertise in data management and analysis will play a crucial role in helping us advance medical knowledge...

  • Clinical Data Management Lead

    1 week ago

    Durham, North Carolina, United States Worldwide Clinical Trials Full time

    OverviewWe're a global, midsize CRO pushing boundaries and innovating to find cures for diseases. At Worldwide Clinical Trials, we're changing the way the world experiences CROs. Our mission is to improve lives with passion and purpose.SalaryThe estimated annual salary for this position is $85,000 - $110,000, depending on location and experience.Job...

  • Senior Clinic Operations Manager

    6 days ago

    Durham, North Carolina, United States Engage Senior Therapy Full time

    About the RoleWe are seeking an experienced and passionate Physical Therapist to fill a role as Senior Clinic Operations Manager in Durham, NH.

  • Senior Cloud Data Scientist

    1 week ago

    Durham, North Carolina, United States ACL Digital Full time

    Senior Cloud Data ScientistThis role is a critical element to utilizing the power of Data Science in delivering Fidelity's promise of creating the best customer experiences in financial services. As a Senior Cloud Data Scientist, you will build and maintain large scale Client Infrastructure and Client pipelines. Contribute to building advanced analytics,...

  • Oncology Therapeutic Lead

    1 week ago

    Durham, North Carolina, United States FHI Clinical Inc Full time

    Job OverviewWe are seeking an experienced Oncology Therapeutic Lead to join our team at FHI Clinical, Inc. in the role of Clinical Research Manager.About the RoleThe successful candidate will be responsible for cultivating relationships with oncology stakeholders, assisting business development in developing an active oncology pipeline, and overseeing the...

  • Senior Clinical Program Manager

    1 week ago

    Durham, North Carolina, United States Seasons At Southpoint Full time

    Seasons at Southpoint: A Leader in Elder CareWe are seeking an experienced Senior Clinical Program Manager to join our team as a key member of our healthcare leadership team. As a Senior Clinical Program Manager, you will be responsible for overseeing the overall health and well-being of our residents, ensuring that they receive the highest quality care...

  • Senior Director of Data Operations

    1 week ago

    Durham, North Carolina, United States RTI International Full time

    Job Description:RTI International is a leading research institute dedicated to improving the human condition. We seek an Vice President of Primary Data Collection to lead our primary data collection operations. This role provides strategic, technical, and operational oversight to single and multi-mode data collection functions, supporting the Data Practice...

  • Clinical Data Analyst

    1 week ago

    Durham, North Carolina, United States Duke University Full time

    Duke University is seeking a Clinical Data Manager to join our team. As a key member of the department, you will be responsible for managing data storage and analysis for clinical research studies.About the Role:50% of your time will be spent working on REDCap/PACE for data storage, while the remaining 50% will focus on entering data for sponsored studies...

  • Clinical Data Specialist, Pharmacovigilance

    3 days ago

    Durham, North Carolina, United States Lifelancer Full time

    About the RoleWe are seeking a highly skilled Clinical Data Specialist to join our Pharmacovigilance team. This is an exciting opportunity for a motivated individual to work with a global team of experts in improving lives through clinical trials.Job ResponsibilitiesCollect, process, and evaluate incoming Serious Adverse Event (SAE) data according to...

  • Senior Statistical Programmer I

    4 weeks ago

    Durham, United States Rho Full time

    Senior Statistical Programmer IJob Location USID 2024-2951Type Regular Full-TimeOverviewJoin us in redefining what it means to work for a CRO. Working at Rho, you'll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity's biggest challenges. At Rho,...

  • Senior Data Engineer

    1 week ago

    Durham, United States CV Library Full time

    Senior Data EngineerDurham, NC -Hybrid -Experience with Oracle databaseStrong hands-on Experience with PL/SQLStrong hands-on Experience with SQLExperience with data conversion and migrationsExperience with data analysis and cleansingExperience with DB2 databaseHands on experience in coding, testing and maintaining ETL processesExperience with source code...

  • Clinic Coordinator

    4 weeks ago

    Durham, United States Engage Senior Therapy Full time

    Job DescriptionJob DescriptionEngage Senior Therapy, a division of CPTE Health Group, provides on-site physical therapy, occupational therapy, speech therapy, and fitness services to senior living communities throughout Greater Boston and Southern New Hampshire. We enrich the lives of our patients through expert, results-oriented, and compassionate care that...

  • Senior Data Engineer

    4 weeks ago

    durham, United States Clinetic Full time

    Clinetic is putting health data in motion for good! We are a health software and technology company helping unleash the potential of electronic health record systems for research, evidence generation, and new care delivery models. We are passionate about developing creative solutions to modernize the way health care is delivered and how clinical research is...

  • Senior Data Engineer

    4 weeks ago

    durham, United States Clinetic Full time

    Clinetic is putting health data in motion for good! We are a health software and technology company helping unleash the potential of electronic health record systems for research, evidence generation, and new care delivery models. We are passionate about developing creative solutions to modernize the way health care is delivered and how clinical research is...

  • Senior Data Engineer

    4 weeks ago

    Durham, United States Clinetic Full time

    Clinetic is putting health data in motion for good! We are a health software and technology company helping unleash the potential of electronic health record systems for research, evidence generation, and new care delivery models. We are passionate about developing creative solutions to modernize the way health care is delivered and how clinical research is...

  • Senior Data Engineer and QA Automation Specialist

    1 week ago

    Durham, North Carolina, United States Fidelity TalentSource LLC Full time

    Job SummaryWe are seeking a highly skilled Senior Data Engineer and QA Automation Specialist to join our Workplace Investing Quality Engineering team at Fidelity TalentSource LLC.About the RoleThis exciting new role within the Workplace Investing (WI) Data Engineering space requires a senior-level professional with expertise in designing, developing, and...

  • Principal Biostatistician

    6 months ago

    Durham, United States SDC (Statistics & Data Corporation) Full time

    Description SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high-quality and experienced team members to develop great medicines that save...

  • Senior Snowflake Data Engineer

    1 week ago

    Durham, North Carolina, United States Hexaware Technologies Full time

    Hexaware Technologies is a global leader in IT Services, driving digital transformation and innovation for businesses worldwide. Founded in 1990, we have grown into a trusted partner for enterprises, offering comprehensive AI empowered services including IT Consulting, Application Development, Infrastructure and Cloud Management, and Business Process...

  • Data Analyst

    6 days ago

    Durham, North Carolina, United States Duke University Full time

    **About Duke University**Duke University is a world-renowned research institution located in Durham, North Carolina.**Job Summary**We are seeking a highly skilled Data Analyst to join our Department of Biostatistics and Bioinformatics. The successful candidate will have the opportunity to develop innovative statistical methods in clinical trial design and...

  • Senior Biostatistical Data Solutions Director

    1 week ago

    Durham, North Carolina, United States PSG Global Solutions Full time

    About PSG Global SolutionsPSG Global Solutions is a leading company in the development of SAS and R programming processes & tools. Our Real World Biostatistics team is experiencing rapid growth, seeking qualified individuals to help develop procedures and standards to improve our efficie Program, Director, Associate, Evidence, Healthcare, Staffing, Process,...