Sr. Data Manager (Sr. Associate)
Location:
Collegeville , Pennsylvania
Posted:
November 20, 2017
Reference:
1113770315

As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Data Manager is responsible for timely and high quality data review and query management of clinical data supporting the Pfizer portfolio. The Data Manager develops and maintains key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data. ROLE RESPONSIBILITIES Serve as Data Manager for one or more clinical trials assuming responsibility for DMM activities including selection and application of data acquisition standards, database design (including specification documentation and testing of clinical data collection tools, both CRF and non-CRF, using an EDC system and/or other data collection systems), development and maintenance of the Data Management Plan, data review and query management, data access and visualization, Data Management metrics reporting, database release, and submission related activities. In collaboration with the Clinical Data Scientist, ensure operational excellence across all DMM deliverables. Ensure work carried out in accordance with applicable SOPs and working practices. Ensure the required study-specific DMM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities. Ensure operational excellence in collaboration with CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities. QUALIFICATIONS Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP Demonstrated knowledge of data management processes and principles in area of responsibility. Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review Demonstrates strong verbal and written communication skills including ability to communicate remotely Minimum 3 years Data Management experience required Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements Proficient experience using commercial clinical data management systems and/or EDC products (e.g. , Inform preferred) Experience using data visualization tools (e.g. Spotfire, J-Review) preferred Familiarity with MedDRA/WHO-Drug Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) Bachelor's degree minimum requirement. Additional Details: Eligible for Employee Referral Bonus Pfizer US/PR Exempt grade 5 EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


A little about us:
Join Pfizer in our mission to find sustainable solutions to the most urgent health care challenges of our time. Your service is needed.

Know someone who would be interested in this job? Share it with your network.