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Head, Data Monitoring and Management Operations

Pfizer


Location:
Peapack and Gladstone, NJ
Date:
11/22/2017
2017-11-222017-12-23
Pfizer
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Job Details

ROLE SUMMARY



As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management organization, the Data Monitoring and Management Head of Operations is responsible for timely and high quality data management deliverables supporting the Pfizer portfolio. This role will establish strategies and services across therapeutic areas including excellence in the application of standards, establishment of advanced, predictive data monitoring practices from database activation through database release and submission. The role will establish and manage enabling functions that support deliverables across all of the DMM Therapeutic areas. This will initially consist of Clinical Data Validation Reporting, Business process and Quality, Training and CDMS User Acceptance Testing.







ROLE RESPONSIBILITIES



The Head of DMM operations will drive the end-to-end redesign and continuous improvement of existing 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 and influential leadership in collaboration with Clinical Operations Group, Clinical, Regulatory and other functions as required. This is a highly 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.



The Role will be responsible for driving key departmental strategic initiatives such as insourcing and the establishment of additional operational teams and geographies as the department evolves into a primarily insourced model.







QUALIFICATIONS



Bachelor or Master Degree in Biological Sciences, Statistics, IT or related field with a strong understanding of biomedical data and analytics. Advanced degree is a plus.



15 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency and at least 10 years in a leadership position.



Strong leadership capabilities including ability to drive strong following in reporting lines.



Experience with Clinical Trial Operations and a clear understanding of clinical data from internal as well as external sources



Demonstrated knowledge of regulatory requirements supporting clinical trials and submissions



Demonstrated experience to manage complex projects and cross-functional teams including delivering to project and portfolio metrics.



Demonstrated strong communication, interpersonal and negotiating



skills in relating to colleagues and associates internal/external to the organization and leveraging of those competencies to ensure continuous progress



Strong track record of building successful relations with supervisors, peers, direct reports, suppliers, customers, partners and stakeholders is essential



Strong strategic experience and business analytics ability to distill research needs and define business, technical, and operational requirements



Expertise in globalizing functions to operate in a standardized fashion. Sound knowledge and experience working across international boundaries and cultures.







Role will require infrequent international and domestic travel



Initial geographic build-ups (e.g. India) will require frequent travel to the location.







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.







Additional Location Information: Groton, CT and Collegeville, PA



Eligible for Relocation Package



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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