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Global Head Clinical Database Management (Senior Director)


Peapack and Gladstone, NJ
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Job Details


As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management organization, the Global Head of Clinical Database Management is responsible for development, validation, deployment, and maintenance of Clinical trial data capture and management methods across trials in support of Pfizer's portfolio. These capabilities enable data capture, review, monitoring and reporting of clinical data. The role will have global accountability of all clinical trial data from the point of generation though delivery to the established analyses and reporting environment. The position has operational leadership of the global team accountable for all clinical trial data capture enabling deliverables with an emphasis on clinical databases supporting the Pfizer portfolio. Accountabilities to include design, development, and maintenance of clinical databases, ensuring the integrity of clinical data and application of standards supporting consistency in asset/submission data. The Global Head of Database Management works closely with the Head of DMM and DMM Therapeutic Area (TA) 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. This role has additional line management responsibilities supporting development, system/technical processes, resources and colleague development. The Global Head of Clinical Database Management will drive the end-to-end redesign and continuous improvement of existing data capture processes / systems / controls to ensure that quality is built-in and to enable best-in-class performance. This position drives and maintains a culture of delivering to established milestones with the highest of customer satisfaction; emphasizing communication and transparency of operations. This will require direct leadership of functional operation teams as well as aligned, influential leadership in collaboration with Clinical Operations Group, Clinical, Regulatory and other functions as required. This is a h i ghly visible, critical position which will require a self-starter with strong leadership, analytical and interpersonal skills who can mobilize, grasp complex systems and processes, and design and implement process, system and line improvements with urgency.


Single point of accountability across all TA's for the delivery of data capture methods across all trials within GPD Provides Sponsorship and establish clear accountability for key processes in Database Management Sets enterprise-wide vision, strategy, and performance objectives for the end-to-end process Establishes clear understanding of key processes including clarity over process inputs, outputs and relationships

+ Manages the Database Management departmental budget and resource forecasts

+ Establishes strong partnerships across DMM, CTS and BT to enable optimized data capture methodologies and dataflow though analyses

+ Ensures alignment across outsourced partners as well as across CS&O for project delivery

+ Anticipates, oversees and influences change to position efficient, high-quality implementation of required data flows to incorporate internal and external data sources into Pfizer informatics environment ensuring operational delivery and traceability from source. Ensures appropriate process and documentation are in place to support inspection readiness.

+ Promotes and oversees data integrity and Key Risk indicators across DMM systems and related methods

+ Identifies, evaluates and prioritizes clinical data reuse opportunities that support portfolio commitments and future horizons of scientific support.

+ Oversees data due diligence activities for in-licensing, co-development, and research collaborations

+ Develops a strong talent base of reporting, testing and standards analysts, ensuring achievement of competency standards and preparing for long-term development needs, via mentoring or matrix management

+ Supports and mentors data monitoring and management subject matter experts to ensure proper process definition and control in support of the highest quality of data management deliverables

+ Ov ersees the processes involved in the collection of clinical trial data


+ Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Science or related field

+ Preference for Masters or doctoral degree

+ Minimum of 15 years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on deploying and managing end to end data collection, assimilation and transformation solutions

+ Minimum of 10 years in a management role with experience in second line management and functional leadership.

+ Must have experience leading large scale EDC/CDMS implementations

+ Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g. data review, study reports, regulatory submissions, safety updates, etc.)

+ Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable

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

+ Oversight of teams developing relational databases (e.g. Oracle InForm, MS SQL Server or MS Access) and data visualization tools (e.g. Spotfire,J-Review).

+ Experience with DMW (Data Management Workbench) a strong plus

+ Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming

+ Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)


Primarily an office-based position involving sitting in front of a computer for large periods of work time, making presentations, etc.


Ability to travel ~5-10%.


+ Relocation eligible

+ Internal candidate identified

+ Eligible for employee referral bonus

+ Posting expiration date (if determined)


+ Reporting to Global Head, Data Monitoring and Management

+ Supports Study and Asset Teams across the Global Product Development, Worldwide Research and Development and other internal organizations. Accountable for establishing and managing operations in the United States, India, China and FSP partners.


**Financial Accountability**

Shared accountability along with peer LT members for overall DMM budget and planning and specific accountability for Global Database Management budget within DMM. Align delivery strategy to ensure responsible, efficient use of resources to deliver analyses required within budget. Accountable for accurate forecasting for future budget estimates and direct reports expenses.


A global team of approximately 50 highly technical contributors through a direct report team of 5 to 8 Associate Directors and Directors.

**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.

**Other Job Details:**

+ Eligible for Employee Referral Bonus

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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