Sr. Clinical Data Manager

Job Description

• The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. • This position will also oversee and/or perform database development and testing • Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs. • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing • May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications • Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. • Provide leadership for cross-functional and organization-wide initiatives, where applicable

Qualifications

• 8+ years’ experience • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook • Able to handle a variety of clinical research tasks • Excellent organizational and communication skills • Professional use of the English language; both written and oral • Experience in utilizing various clinical database management systems • Broad knowledge of drug, device and/or biologic development and effective data management practices • Strong representational skills, ability to communicate effectively orally and in writing • Strong leadership and interpersonal skills • Ability to undertake occasional travel • Experience in a clinical, scientific or healthcare discipline • Dictionary medical coding (MedDRA and WHODrug) • Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) • Oncology and/or Orphan Drug therapeutic experience

Benefits

• Any data provided as a part of this application will be stored in accordance with our Privacy Policy. • Reasonable estimate of the current range: $80,000 — $120,000 USD. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.