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Senior Associate, Senior Data Manager, Clinical Data Sciences

Employer
Pfizer
Location
La Jolla, California, United States;Boulder, Colorado, United States;Collegeville, Pennsylvania, United States;Cambridge, Massachusetts, United States;
Salary
Competitive
Closing date
Sep 25, 2022

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Discipline
Physical Sciences, Information Technology
Position Type
Full Time
Job Type
Manager
Organization Type
Pharma
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Why Patients Need You

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve

It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility. You will play an important role in processing, reviewing and receiving clinical data and records and from therapeutic groups as well as internal and outside investigators. You will ensure that accurate, timely, and consistent data reaches the clinical teams and other groups. You will be relied on for data management plans, including data preparation and validation activities, among others.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.

It is your commitment and hard work that will help make Pfizer ready to achieve new milestones and help patients across the globe.

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 maintainskey 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 or at least 12 years of relevant data management pharma industry experience.
  • Ability to travel ~5%


#LI-PFE

Relocation assistance may be available based on business needs and/or eligibility.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

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.

Medical
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