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Title:Sr. Clinical Data Manager
Salary:Open
Experience:7+
Location:CA - Brisbane

Description:
The Sr. Clinical Data Manager provides a clinical data management support to cross-functional team members in a new drug development or a post marketing program. The Sr. CDM leads planning and executing different stages of CDM support of clinical trials.

Responsibilities:
  • Participates in development of functional group objectives aligning with the department objectives.
  • Manages and/or executes the completion of CDM deliverables to meet project timelines.
  • Leads data collection and management activities from development to finalization: case report forms (CRFs) or eCRFs, including user acceptance tests (UATs), edit checks, data management plans, AE/medication coding, and submission datasets preparation using the CDISC compliance format.
  • Monitors every aspect of data management deliverables quality from data collection design to database lock.
  • Leads or participates in department special project teams focused on improving business operations and process improvement.
  • Fosters open communications among cross-functional groups within the department as well as outside of the department to establish seamless and transparent workflows.
  • Negotiates effectively to meet study objectives
  • Investigates trends, identifies techniques, and makes recommendations for new methods and techniques used in pharmaceutical and /or biotech industries for reporting and managing clinical data.
  • Develops CDM SOPs.
  • Participate in overseeing CROs

Requirements:
  • Minimum educational degree is a Bachelor of Science.
  • Preferred an individual who has a certification of CDM and has used or developed eCRFs for data collection.
  • A minimum of 7 years Pharmaceutical, Biotech, or equivalent health care industry experience.
  • Thorough knowledge of data management function in drug development from pre-clinical to regulatory submission including data collection practices and data flow requirements to support statistical analysis,
  • Experience working on clinical projects intended for regulatory submissions for market approvals.
  • Thorough working knowledge of case report forms, data and form standards, database design, edit check development, data management plan development, including data specifications for the data provided by 3rd parties in clinical trials.
  • Ability to perform systematic data quality control management.
  • Ability to document deliverables following procedures with the utmost rigor and attention to detail.
  • Knowledge of CDISC requirements for SDTM and ADaM dataset structures is desirable.
  • In-depth knowledge of electronic Clinical Data Management systems and processes.
  • Familiarity with Medidata RAVE and other EDC tools is preferred.
  • Ability to develop and implement high data quality control system and/or procedures.
  • Worked on NDA and/or BLA submissions, preferably via electronic Common Technical Document.
  • In-depth knowledge of regulatory regulations and guidelines in drug development and approval.
  • Basic to intermediate knowledge of SAS in UNIX and Window is desirable.
  • Intermediate and advanced understanding of computers at system level: working knowledge of Oracle, SQL, and RDBMS is desirable.
  • Proficiency in MS Word, Excel, and PowerPoint
  • Working knowledge of MS Project and Visio is desirable
  • Must be able to build a rapport and trust with others through dependability.
  • Must be self-motivated and able to work well under pressure and shifting priorities independently and as a team member.
  • Ability to plan, implement, and manage multiple simultaneous projects and deadlines with shifting priorities and resources.
  • Ability to document and communicate progress toward project milestones in a clear and consistent manner, leveraging appropriate tools, e.g. MS Project.
  • Self-directed to complete complex tasks in a timely manner with a minimal supervision.
  • Must be able to initiate clear and effective communications across disciplines or divisions in the company.
  • Effective at explaining technical concepts to a varied audience in both an individual and group setting.
  • Capable of well organized, concise, and clear written and verbal communication.
  • Effective presentation skills.

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