Senior Clinical Data Manager
Confirmed live in the last 24 hours
Remote • New York, NY, USA
Experience Level
  • Bachelor's degree in Health Sciences, Clinical Data Management, Nursing or other relevant scientific field, or equivalent work experience is required
  • 5+ years relevant experience within the Pharmaceutical, CRO or Biotech industry, or equivalent is required, with demonstrated knowledge, experience and ability to perform to meet high quality standards and high level of customer satisfaction
  • Demonstrated in-depth understanding of clinical trial data concepts, processes and procedures, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards
  • Demonstrated leadership in clinical data management activities and a desire to excel in leading data management projects
  • Assist in the development and maintenance of the Data Management Plan (DMP). Document deviations from the Plan, log and report issues, and follow up on their resolutions
  • Is the primary contact person for communication and discussion of topics related to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues
  • Assist in the planning and implementing of data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting
  • Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel
  • Participate in regular project management team meetings
  • Assist in the design and review of case report forms (CRFs/eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms
  • Assist in the development and maintenance of data validation specifications
  • Assist in the development and maintenance of the Data Management Plan (DMP) and Data Validation Plan (DVP). Document deviations from the DMP
  • Participate in the database design process. Participate in EDC User Acceptance Testing (UAT)
  • Manage the process of database modifications (after go-live) due to protocol amendments or study needs
  • Perform Third Party non-CRF data management activities
  • Review data, issue and resolve queries. Assist Investigative Site personnel with resolving queries
  • Perform Serious Adverse Event reconciliation
  • Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products
  • Perform database soft-lock and hard lock activities
  • Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation

51-200 employees

Drug development partner
Company Overview
TrialSpark's mission is to new bring treatments to patients faster and more efficiently by reimagining the clinical trial process.
  • Flexible Time Off - We have a flexible PTO policy so you can find time to recharge, take care of personal matters, and fully enjoy your dream vacations.
  • Parental Leave - We believe your personal life enriches your professional one. We offer 16 weeks of paid parental leave for birthing parents and 12 weeks for non-birthing parents so you can start or grow your family.
  • Comprehensive Benefits - All full time employees have access to health, vision, and dental insurance. Additionally, we provide pre-tax commuter benefits, access to a 401k plan, short and long-term disability and life insurance.
  • Equipment Reimbursement - Employees receive a monthly cell phone stipend, as well as an equipment reimbursement to use to set up a home office.
  • Education & Career Development Resources - TrialSpark offers a plethora of professional development resources to employees. Some examples include fireside chats with industry experts, conference passes, certification courses, internal mobility opportunities, in depth manager training, leadership coaching program, and more.
  • Hybrid Work Environment - Most employees split their time working both at the office and home, while some of our colleagues are fully remote. We have dedicated days when all NYC-area employees work together from the office (for most, this is two to three days per week), and on other days, employees choose their own work location.
  • Team Bonding - Our team likes to get outside the office. You can count on colleagues organizing optional events that aren't your standard happy hour (think rock climbing, food tours, etc) and we have many virtual events to connect with our full remote team (cooking classes, watercolor painting, drag queen bingo, improv, and many more!). Plus, you can put your personal values into practice by joining an Employee Resource Group, including Allyship, TrialSparQ and Women at TrialSpark.
  • Newly Renovated Office - Our beautiful, bright, and plant-filled new NYC headquarters is conveniently located within walking distance to the PATH, Grand Central Station, and Penn Station. Our work environment is collaborative and lively, with cross-functional teams regularly working and socializing together. We fuel our teams with drinks, coffee, and snacks always on hand.
Company Core Values
  • Think in first principles - At TrialSpark, we are looking to disrupt an established industry. We interrogate decisions and solve problems from first principles – we don’t do something just because that’s the way it’s always been done. By approaching work with curiosity and purpose, we believe we can achieve results that seem impossible on the surface.
  • Be a scientist - Our mission oftens leads us into uncharted territory, where the best path forward is not obvious. At TrialSpark, we value scientists: people who are able to structure ambiguity and boldly carve a path forward through experimentation, iteration, and reflection. We problem-solve without ego and learn from mistakes.
  • Deliver care - Given our immense ambitions, the path to success will be long. We believe in caring for ourselves and others along the way by building an environment of trust, transparency, and growth. We strive to make TrialSpark a diverse, equitable, inclusive work environment where all are committed to helping each other grow and feel they belong.
  • Champion the mission - Our mission – to bring new treatments to patients faster and more efficiently – is our north star. At TrialSpark, we elevate the mission in everything we do: the decisions we make, the work we choose to do, and the people we choose to work with. Because when you’re developing tomorrow’s life-changing treatments, every day matters.