8 days old

Data Acquisition Information Manager

Pfizer
Groton, CT 06340
Why Patients Need You Technology impacts everything we do. Pfizer's digital and 'data first' strategy focuses on implementing impactful and innovative technology solutions across all functions from research to manufacturing. Whether you are digitizing drug discovery and development, identifying solutions, or making our work easier and faster, you will be making a difference to countless lives.

What You Will Achieve This position is responsible for providing leadership, collaboration and expert execution of clinical data acquisition tasks for the Information Management Data Acquisition team. Incumbent will partner with Digital, Data Management and other business stakeholders to ensure related activities are fulfilled with data integrity according to defined requirements and timelines.

This role is responsible for the implementation and management of electronically sourced clinical data throughout Pfizer Global Research and Development.



The position will assist in the implementation of process, policy and resources related to acquisition of clinical data and its availability to downstream systems. The role will be required to take ownership of new and ongoing projects within the overall initiative, while engaging a variety of stakeholders and customer groups to ensure study teams are enabled to consume e-source data in clinical studies efficiently, consistently and with the highest quality and lowest regulatory risk.



This role demands the ability to support technical changes which include the identification and improvement of processes and applications to mitigate risk and impact. Work both autonomously on assigned work items, as well as being a member of a strongly interactive team. Skill set of potential candidates must include expertise in process development and successful history of project execution and delivery.

How You Will Achieve It



+ Provide technical support of non-CRF data related activities including multiple data providers and CROs currently supporting these activities. This role will assist in coordinating and overseeing all non-CRF data activities, training, and performance of CROs/Partners across projects from a functional perspective.

+ Responsible for managing and overseeing the setup and conduct activities for studies using CONFORM (Data Acquisition platform).

+ Provide technical expertise and business process support including new and legacy processes/systems implementation - support system release by providing technical and process expertise training. Provide subject matter expertise and support of Pfizer EDC systems, Oracle Clinical and Inform DMW for non-CRF data activities

+ Support and or lead continuous improvement initiatives to realize efficiencies within the system and supporting processes to continue to ensure data quality.

+ Work collaboratively and support study teams including Data Management and Monitoring (DMM) as key escalation point and facilitate resolution of issues raised by individual project teams.

+ Metrics - Ensure non-CRF data activities and performance are on target and meet established timeframe and quality expectations. Use of production and tracking metrics for non-CRF data activities occurring at CROs/Partners to develop more efficient processes to decrease cycle times of individual activities in specialty areas.

+ Ensure data standards are implemented into file specifications and data mapping and oversee adherence by CROs and data providers. Identify needs for new or amended data standards and initiate discussion with relevant colleagues and TA standard boards. Interact with Clinical Data Scientists (data managers) to increase utilization of existing standards.

+ Ensure that all systems are in compliance with GCP, relevant SOPs, and regulatory requirements including but not limited to 21CFR11.

+ Provide technical expertise and knowledge during audits in area(s) of specialty.



Qualifications Must-Have



+ Demonstrated customer relationship skills and capabilities and collaboration on teams

+ Excellent written and verbal communication skills

+ Proficient in English

+ Background - BS in computer science or equivalent

+ Strong background in Clinical Data Management and good understanding of Good Clinical Practice and ICH Guidelines

+ Strong experience i.e. 5+ years in related field

+ Experience in Programming Language, SQL (Structure Query Language), Clinical Data Management Systems, Understanding of cloud computing

+ Experience in Microsoft Office suite

+ Good oral, written communication and interpersonal skills

+ Attention to details and aptitude for learning new systems

+ Familiarity with System Development Life Cycle would be a plus



Nice-to-Have



+ Master's Degree

+ Ability to keep abreast of current regulatory and technical trends and howthese trends would impact Data Acquisition needs.

+ **ROLE SUMMARY** Individuals filling the position are responsible for providing deep subject matter expertise and strong execution/delivery in the management of Global Product Development applications as well as integration and support activities to ensure the compliance of the Information Management, Operations Center of Excellence . Incumbent will be the strategic bridge between business functional lines and Pfizer Digital technology. Your technical and business skills will help Pfizer support and elevate the functioning of business information processing systems. Your knowledge of computer systems, business processes and workflows will make you a critical member of the team. Your strong communication skills will facilitate requirement gathering for building and enhancing business process maps and systems. Your business process and technical knowledge will help us develop new systems and modify existing business applications. **ROLE RESPONSIBILITIES**

+ Oversee systems integration projects across the Information Management portfolio domain.

+ Establish an information quality plan and oversight.

+ Coordinates the integration of information management solutions into business processes Serve as the Point of Contact (POC) to manage the mapping, planning, and integration of content for newly in -scope business areas, acquisitions, collaborations, divestitures.

+ Ensures that the company's critical information and records stored within COE -owned repositories are managed in accordance with external regulations and internal processes, are protected and controlled over the long term and that data/content is available for critical bus iness needs and is retained in accordance with established retention schedules.

+ Lead medium to large projects, following established methodologies.

+ Support compliance activities for internal and external inspections and audits, interfacing with company and agency professionals as appropriate.

+ **QUALIFICATIONS**

+ Bachelor's Degree with 9+ years of experience in the healthcare/ pharmaceutical industry, including an understanding of the drug development process. .

+ Demonstrated, in depth knowledge of Healthcare and/or Pharmaceutical drug development environment and regulations .

+ Demonstrated experience with identifying inefficiencies and/or gaps in processes as well as the ability to propose solutions and/or lead teams challenged with delivering process improvement initiatives or associated system/technology enhancements.

+ Capacity to make appropriate business decisions in evolving business environment, as well demonstrate flexibility and tolerance for ambiguity & uncertainty.

+ Ability to interface with international colleagues, understand the "big picture" in terms of potential implications of changes to systems and processes to sites and/or affiliates outside of home country/regio n.

+ Demonstrated customer relationship skills and capabilities and collaboration on teams.

+ Demonstrated ability to perform in a cross -functional environment.

+ Strong verbal, written communication and presentation skills.

+ Strong demonstrated project m anagement and organizational skills.

+ Knowledge of application system management and change control processes, application validation and implementation in a GxP environment.

+ Knowledge of Healthcare/ Pharmaceutical metadata and standards.

+ Experience with query tools/data extraction techniques (e.g., SQL, PL/SQL, Brio, MS_Access ) preferred.

+ Experience authoring business user requirements, coordinating validation -related efforts (e.g., Business User Acceptance Testing), performing quality assu rance reviews of test scripts.

+ **Other Job Details:**

+ **Last Date to Apply for Job: November 26, 2020**

+ Eligible for Employee Referral Bonus: YES



\#LI-PFE



**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.



Information & Business Tech

Categories

Posted: 2020-11-16 Expires: 2020-12-16

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Data Acquisition Information Manager

Pfizer
Groton, CT 06340

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