Senior Clinical Data Manager, Bio-Oncology

Yoh has a long term contract opportunity for a SR. CLINICAL DATA MANAGER, BIO-ONCOLOGY to join our client, the world leader in the pharmaceutical industry, located in South San Francisco, CA.

JOB RESPONSIBILITIES:

- Clinical Data Management (CDM) resides within the Data Management and Programming Function in the Department of Biometrics, Health Outcomes and Payer Support (BHOPS) in US Medical Affairs (gMed).
- Members of the CDM group are allocated to work in one of three Disease Biology Areas (Bio-Oncology, Autoimmune/Ophthalmology/Asthma and Virology/Specialized Products) and report to the Head of Data Management for the individual Therapeutic Area.
- Individual Data Managers (DM) work as members of the Study Management Team for a sponsored clinical trial (or Registry) to oversee the completeness, accuracy and internal consistency of the data for the trial.
- Additionally, DMs may be required to generate data tabulations, profiles and listings to support Medical and Clinical colleagues with the monitoring and clinical review of the data, or status reports, to inform the SMT of the study progress.
- Members of the CDM group use a variety of tools to assist them with their responsibilities, including clinical data browsers (such as Hyperion Brio), SAS, and Electronic Data Capture (EDC) Systems, such as Oracle Inform or Medidata Rave.

JOB QUALIFICATIONS:

- A minimum of seven to ten (7 - 10) years of clinical data management experience in a pharmaceutical or biotechnology company or clinical research organization (CRO) essential, with a BS or higher in a bio-medical discipline (eg Biological Sciences, pharmacology etc).
-.Working in a fully outsourced model* very important.
- Proven experience in the management of consultants and/or staff at an external vendor is essential.
- Proficient in the use of database management systems (such as Oracle Clinical, ClinTrial, Medidata Rave or Oracle INFORM.
- Proficiency in the use of clinical data browsers (such as Hyperion Brio) essential
- Knowledge and familiarity with database theory, specifically relational database concepts.
- Good interpersonal skills. Good verbal and written communication skills.
- Experience with desktop tools.
- Ability to work on multiple tasks simultaneously and meet project deadlines.
- Demonstrated ability to interact confidently with members of other functional areas in study teams.
- Thorough understanding of regulatory guidelines (such as ICH guidelines E6) Competence in SAS Programming Language will be a positive advantage.
- Thorough understanding of the clinical trials process.
- Extensive previous experience of working in a pharmaceutical marketing environment with data from phase IV clinical trials is an advantage.
- Working knowledge of CDISC SDTM standard is a positive advantage.
- Participation in a regulatory filing, such as in the development of an e-submission or CTD will be a plus.
- Experience interacting with others for defining and implementing data listings/patient profiles.
- Experience in working in teams and communicating one-on-one and with group.

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Salima Hakim

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry. 

Yoh, a Day and Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: INFOTECH; J2W: CLINICAL

Tax Term: CON_W2

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SFSF: LS