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Program Lead, Data Monitoring and Management (Director)


Peapack and Gladstone, NJ
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Job Details


The Data Monitoring and Management Group Lead serves as the primary Data Monitoring and Management (DMM) point of contact at the asset level. The primary purpose of the role is to ensure provision of internal and external strategic and operational leadership and expertise in data monitoring and management with an emphasis on effective partnering. Accountabilities include the design, development, and maintenance of key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, overseeing the application of standards, data review and query management, as well as ensuring quality study data set release and consistency in asset/submission data. Excellence in the delivery of data management deliverables is a result of effective and efficient partnering with both external partners/vendors and internal partner (e.g. DevOps China). The DMM Group Lead works closely with the DMM Head and Therapeutic Area Leads to ensure the DMM team functions as a harmonized unit with consistent, timely and high quality application of process and delivery of DMM responsibilities. Additional responsibilities will include managerial oversight and as needed technical support of Clinical Data Scientists (CDS), resource management and workload prioritization.


+ Acts as the key scientific and technical data management expert at the asset level; define and drive the data management strategy and standards for the Therapeutic Areas (TA) as well as Risk Based Monitoring (RBM) standards, tools, data provisioning, and reporting

+ Builds and oversees a high performing team of Clinical Data Scientists to deliver data monitoring and management expertise to Research/Business Units and other Global Product Development lines in a high quality and timely manner

+ Serves as a functional driver of Quality Gates and manages Significant Quality Events (SQEs)

+ Anticipates, oversees and influences change to position efficient, high-quality operational delivery

+ Develops creative solutions to complex problems within and beyond scope of expertise (e.g. TA, discipline, department)

+ Assumes accountability and as needed responsibility for all DMM activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, and third party study data due diligence and deliverables

+ Manages risk appropriately to enable innovative solutions

+ Establishes strong partnerships with BU/RU, department leadership and other functions to advance asset or indication goals

+ Ensure work carried out by DM providers/vendors is in accordance with applicable SOP's and working practices.

+ Ensures DM work is inspection ready and acts as a key data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups within Pfizer.

+ Helps develop a strong talent base within group of Clinical Data Scientists, preparing for long-term development needs, via mentoring or matrix management


+ Bachelor's degree required. Degree in scientific field preferred. Master's degree preferred.

+ Knowledge of vendor processes and best practices in outsourcing. Must be capable of building strong relationships with Partners and other vendors.

+ At least 10 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency.

+ Supervisory experience required

+ Data Management and clinical trials expertise with a thorough understanding of the processes associated with clinical drug development and data analysis operations required for the reporting of clinical trials and global regulatory submissions.

+ Thorough understanding of regulatory requirements and relevant data standards. CDISC knowledge and experience are preferable.

+ Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills

+ Sound knowledge and experience working across international boundaries and cultures.

+ Can be remote based, but office location are available and desired

**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.
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