Director, Program Lead, Clinical Data Collection Strategies
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Job Location:
New York City, NY - USA
Monthly Salary:
$ 169700 - 282900
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
ROLE SUMMARY
As part of the Clinical Data Collection Strategies (CDCS) group an integral delivery unit within the CDIS (Clinical Data and Information System) organization the Director Program Lead Clinical Data Collection Strategies is responsible for the provision of operational leadership and expertise in data monitoring and management with an emphasis on clinical databases supporting assigned segments of the Pfizer portfolio.
Accountabilities to include design development and maintenance of clinical databases ensuring the integrity of clinical data application of standards supporting consistency in asset/submission data.
The CDCS Group Lead works closely with the Global Head of CDCS Database Management Program Leads and CDS Therapeutic Area (TA) Leads to ensure the CDS team functions as a harmonized unit with consistent timely and high-quality application of process and delivery of CDS responsibilities. The Clinical Database Management Group Lead will be accountable to assure technologies and standards are leveraged in a consistent way across a program.
This role has additional line management responsibilities supporting development system/technical processes resources and colleague development.
ROLE RESPONSIBILITIES
Works 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 per standard and study specific data review plans.
Complies with applicable SOPs and work practices
Serves on the data standards board as needed and leads as needed implementation and where needed development of data management reporting standards.
Serve as a technical resource to the study teams for data capture and assimilation deliverables.
Ensure operational excellence in collaboration with partners and colleagues for application of standards within data capture methods in support of the data review plan in collaboration with the Clinical Data Scientist ensure operational excellence across all CDS deliverables
Directly supports knowledge development of data capture tools and methods that support the accuracy and integrity of study data
Identifies existing process/product improvements
Develops innovative advanced new concepts that improve processes / products across own and related disciplines
Takes appropriate risks to achieve desired results
Recognizes development needs and identifies/creates development opportunities within own team
Develops a talent base and anticipates development needs within the area of responsibility
QUALIFICATIONS
Bachelors degree in Statistics Biostatistics Mathematics Computer Science or equivalent
Minimum of 7 years of relevant experience in a pharmaceutical biotech CRO or Regulatory Agency with an emphasis on building data collection and assimilation solutions
Minimum of 4 years in a management role with experience in second line management and functional leadership
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
Technical skills and experience using relational databases (e.g. Oracle InForm MS SQL Server or MS Access) and data visualization tools (e.g. Spotfire J-Review)
Experience in Oracle PL/SQL SAS Java relational database design and database programming skills
Proficiency in the use of Microsoft Office Suite of tools (Outlook Word Excel etc.)
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers develop and coach others oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
PHYSICAL/MENTAL REQUIREMENTS
Primarily an office-based position involving sitting in front of a computer for large periods of work time making presentations etc.
Work Location Assignment:Hybrid
Relocation assistance may be available based on business needs and/or eligibility.
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 providers 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. This position requires permanent work authorization in the United States.
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Required Experience:
Director
Key Skills
- Nurse Management
- Program Management
- Employee Evaluation
- Management Experience
- Teaching
- Curriculum Development
- Administrative Experience
- Budgeting
- Leadership Experience
- Program Development
- Supervising Experience
- Addiction Counseling
About Company
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