Pfizer

Associate Director, Clinical Data Management

Employer
Pfizer
Location
Cambridge, Massachusetts
Salary
Competitive
Posted
November 19 2020
Ref
4790374
Position Type
Full Time
Organization Type
Pharma
ROLE SUMMARY

We are looking for a self-directed data management professional to support clinical data management efforts for Digital Medicine & Translational Imaging (DMTI) projects and the Pfizer Innovation Research (PfIRe) Lab.

You will manage highly complex clinical data management projects and be responsible for clinical data management tasks to collect, code, process, review, and validate clinical trial data received in-house and remotely. You will ensure collection of complete, accurate, high quality, regulatory compliant data in support of publications and regulatory submissions according to external regulatory requirements, and internal standard operating procedures (SOPs) and deadlines.

You will be responsible for the development and execution of data management plans for wearable device and remote monitoring clinical studies, working closely with a motivated and engaged core team of clinical, technical, and data scientists. You will act independently as a senior data manager on study teams seeking to develop and validate novel digital endpoints across different therapeutic areas.

In close partnership with colleagues from the Worldwide Research, Development & Medical Research Units and asset teams from the Global Product Development, you will play a key role in the deployment of novel digital endpoints into clinical studies, collection, management and analysis of sensor data, both in patients and healthy volunteers. You will need to communicate effectively with the DMTI Leadership Team, lead colleagues within a matrix organization, and leverage information from a variety of sources in order to effectively understand organizational and study level strategy to help drive study decisions.This role will be central to the deployment and scaling of digital solutions into clinical trials where these technologies may be utilized as efficacy endpoints and provide value to key stakeholders including patients, physicians, payers, and Pfizer.

ROLE RESPONSIBILITIES

  • Develop CRFs according to CDISC standards
  • Processes, reviews, and receives patient data and records and organizes clinical data forms from internal therapeutic groups and outside investigators
  • Provides accurate, timely, and consistent clinical data to the study teams.
  • Responsible for data management plans including data preparation, data validation activities according to Pfizer SOPs
  • Contributes technical expertise toward the design, implementation and scaling up of sensor systems and analytics.
  • As a data manager, is accountable for collection, organization, curation, storage and safeguarding of patient data from PfIRe Lab, asset teams, and external collaboration studies in a manner consistent with 21CFR part 11.
  • Contributes to the overall architecture of the existing data pipelines and workflows, recommends and implements improvements.
  • Contributes to establishing good clinical practice (GCP) in the PfIRe Lab; authors SOPs for PfIRe Lab; ensures that DMTI processes meet business requirements and industry best practices, while being compliant with Pfizer policies and standards.
  • Tracks emerging study data and works closely with bioengineering and quantitative colleagues to ensure the effectiveness of tools and data quality
  • Shares learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications.


BASIC QUALIFICATIONS

  • Bachelor's degree in a scientific discipline or equivalent work experience
  • 10 years of relevant pharmaceutical, biotech, or CRO experience in clinical data management
  • Working knowledge of medical terminologies: MedDRA and WHO-DD
  • Working knowledge of SDTM and CDASH principles
  • Understanding of regulatory requirements for data management and the regulatory submission process
  • Proficiency with at least one electronic data capture (EDC) system, e.g., Oracle InForm or REDCap Cloud
  • Strong interpersonal and leadership skills
  • Demonstrated the ability to build consensus and drive change across the organization
  • 2+ years' experience with:
  • AWS or other cloud-based development
  • Python
  • Unix/Linux environments
  • #LI-PFE


PREFERRED QUALIFICATIONS

  • Master's degree in a related science field
  • Certified Clinical Data Manager (CCDM) from the Society of Clinical Data Management


Ability to perform mathematical calculations and ability to perform complex data analysis

N/a

Relocation support available

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.

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