Clinical data management Jobs in Philadelphia, PA

About Madrigal : Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.Role Overview : Clinical Data CoordinatorThe Clinical Data Coordinator (CDC) is responsible for supporting clinical data management activities to ensure the collection, review, and processing of high-quality clinical trial data in compliance with regulatory requirements and industry best practices. The CDC will work closely with cross-functional teams, including Clinical Operations and Biostatistics, to ensure the integrity and accuracy of clinical data throughout the study lifecycle.Position Responsibilities : Responsible for ensuring the completeness, quality and integrity of the Clinical Trial data.Ensure data quality and consistency according to applicable regulatory requirements, standard operating procedures (SOPs), processes and data standards.Ensure all data management activities to be compliance with GCP, relevant regulatory requirements and SOP / WI (work instructions) of CRO and / or Sponsor.Direct data management responsibilities include, but not limited to, the following : Conduct data validation, and quality control checks to ensure data accuracy and completeness.Assist in the development, review, and maintenance of Case Report Forms (CRFs) and electronic data capture (EDC) systems.Perform data cleaning activities with clinical sites and study teams including discrepancy management (review of errors from electronic checks) and manual review (review of data listings).Collaborate on the development and review of relevant documents as assigned, e.g., Data Management Plan, UAT Plan, Data Review Plan and CRF Completion Guidelines, etc.Participate in internal / external functional meetings as required.Monitor the progress of data collection and provide reports on study metrics, discrepancies, and data trends.Collaborate with vendors and external partners involved in data collection and database development.Participate in database testing, user acceptance testing (UAT), and database lock activities.Support audit and inspection readiness activities, ensuring compliance with regulatory and company standards.Qualifications and Skills Required : Bachelor's Degree or higher in a Life Science, Health Informatics, or related field.1-3 years of clinical data management experience, preferably within a pharmaceutical, biotech, or CRO setting.Knowledge of ICH-GCP, FDA, EMA, and other relevant regulatory guidelines.Familiarity with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault EDC) and clinical data management processes.Proficiency in Microsoft Office Suite and database management tools with understanding of database structures.Preferably strong knowledge and experience with use of advanced functionality within MS Word and Excel (pivot tables, VLOOKUP, etc.)Strong attention to detail, analytical skills, and ability to manage multiple tasks in a fast-paced environment.Excellent oral and written communication skills in English.Strong problem-solving and time management skills.High degree of enthusiasm and a strong sense of responsibility.Adapt to work with highly-accurate, highly-attention of details, and strict quality control.Ability to work in team setting as well as independently with minimal instruction.Compensation : Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect / fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you : do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.