Pfizer

Associate Director, Asset Lead Central Monitor, Risk Based Monitoring, DMM

Employer
Pfizer
Location
Remote, Connecticut
Salary
Competitive
Posted
May 06 2021
Ref
4811892
Position Type
Full Time
Organization Type
Pharma
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 Manager, you will be setting the objectives for multiple projects in your division. Your managerial and technical skills will help in guiding the people in your division. Your understanding of the external marketplace and customer requirements will facilitate in instituting knowledge sharing practices in your team and outside. You shall be relied on to manage operational activities that support the goals of the division and sets direction for its success.

The Asset Lead Central Monitor is responsible for timely and high-quality central monitoring deliverables supporting the Pfizer portfolio. This role delivers asset level strategies and services for optimal use and reuse of risk-based monitoring methodology to advance the research, development, and commercialization of the Pfizer portfolio. The Asset Lead Central Monitor is expected to oversee the central monitoring of large or several smaller assets and may directly or indirectly participate in study activities such as CRF Development, risk analysis, defining and programming analyses in the central monitoring platform, e.g. CluePoints, interpreting and presenting key risk indicators (KRIs) and data quality assessments (DQAs) that identify emerging study-specific risks including data trends and outliers. The Asset Lead Central Monitor may have direct reports.

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

How You Will Achieve It

  • Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality central monitoring processes to meet expected quality, timelines, and deliverables.
  • Act as the key scientific and technical central monitoring expert; drive central monitoring strategy within Pfizer's risk-based model, defining central monitoring standards for the asset, Therapeutic Areas (TA), or global organization.
  • Serve as Subject Matter Expert (SME) for and oversee the central monitoring activity for one or more asset. Train and mentor colleagues and study teams on central monitoring techniques and strategy.
  • As needed, serve as Central Monitor for one or more clinical trials assuming responsibility for all Central Monitoring activities including analytics of aggregate data to identify issues and risks at the study and asset level. Ensure risks are addressed consistently across the asset.
  • Utilize various programming techniques, e.g. YAML script, SAS code, SQL query, to extract and analyze operational and clinical trial data from various information systems. Analyze, interpret, and summarize statistical output from risk-based quality management software, e.g. CluePoints
  • Participate in process improvement initiatives to develop, embed, and grow business processes to support Pfizer's risk-based monitoring methodology.
  • Set objectives for and manage multiple projects within a division.
  • Develop a talent base and anticipates development needs within the area of responsibility.
  • Identify existing process and product improvements.
  • Work closely with department roles and cross-functional study team members to create data capture solutions that support the quality and timely delivery of data required as per standard and study specific data review plans.
  • Understand the drug development process and data operations required for the reporting of clinical trial data.


Qualifications

Must-Have

  • Bachelor's Degree. Degree in Life Sciences, Informatics, or Computer science, or Statistics, or related business degree with equivalent experience preferred.
  • 7+ years' experience
  • Demonstrated relevant experience in a pharmaceutical, biotech, Contract Research Organization (CRO), or Regulatory Agency with an emphasis on building data collection and assimilation solutions
  • Demonstrated experience managing complex projects and developing successful partnerships within and across functional areas
  • Understanding of regulatory requirements and relevant data standards
  • Strong communication, decision-making, influencing, negotiation, and project management skills
  • Technical skills and experience using relational databases and data visualization tools , e.g. Spotfire, JReview
  • Strong people management experience. Proven leadership experience in a global, matrix environment
  • Broad exposure to programming in a clinical trial environment, e.g. Python, R, SAS, SQL, EDC systems


Nice-to-Have

  • Master's degree
  • CDISC (Clinical Data Interchange Standards Consortium) knowledge and experience


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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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