Process Lead
Location:
Groton , Connecticut
Posted:
November 23, 2017
Reference:
1817063593

The Process Lead is a Subject Matter Expert (SME) on assigned processes/SOPs. Will be the point of contact and technical expert for study teams. Seeks out, identifies and drives efficiencies and process improvements. • The Process Lead provides project management support to relevant Business Process Owners (BPOs). • Partners with BPO to provide support for integrated/acquired studies, vendor assessment, audits, inspections and significant quality events (SQE). • The Process Lead interfaces with the Clinical Development Quality, the BPO Network, external partners/CROs, and SOP & Training group as point of contact for assigned processes/SOPs, e.g., regarding SOP updates or training • The Process Lead will review metrics and trend reports to identify, assist and recommend mitigations for issues at the enterprise level including CAPAs where appropriate, and to support individual study teams where necessary. Responsibilities: Applies subject matter expertise to the improvement, maintenance and oversite of assigned processes and SOPs. The Process Lead will champion the implementation and use of harmonized, consistent processes and excellence in process performance related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals. Direct support of study teams and sharing of best practices. The Process Lead will provide logistical and project management support to the relevant BPOs, which may include chairing meetings, providing minutes, and provision of training The Process Lead will provide process-specific support for integrated/acquired studies, vendor assessments, SOP equivalency assessments, inspections, audits, SQEs, etc. The Process Lead will analyze assigned process/SOP metrics across the enterprise for trends and lead design and integration of process/SOP-level remediation as required, in cooperation with the BPO The Process Lead partners with the BPO on the roll out and implementation of new processes, assessing learning gaps and opportunities within the organization and identifies quality goals and standards, supporting a culture of high quality by creating, updating and improving tools to facilitate consistency, quality and transparency. The Process Lead partners with the Clinical Medical Controlled Documents (CMCD) author to create new or update existing required forms, supporting documents, and other CMCD documents for the assigned processes/SOPs. The Process Lead partners with Business Technology and Information Management to provide business process requirements for systems/tools related to the assigned process/SOP. The Process Lead serves a point of contact for Trial Master File operations for the assigned process/SOP. Training and Education: Extensive global clinical trial/study management experience Working knowledge of GCPs, monitoring, clinical and regulatory operations BS - minimum of 10 years relevant experience MS/PhD - minimum of 7 years relevant experience Prior Experience Preferred: Demonstrated effectiveness working in a multidisciplinary, matrix team environment required Demonstrated leadership on initiatives, integrations and process improvement work streams Evidence of Clinical Development and pharmaceutical study execution experience; thorough understanding of the processes required to operationally execute clinical trials is preferred Evidence of strong leadership, influencing, negotiation, and management skills is preferred Capabilities/Skills Understands how to work with multi-functional groups and teams to accomplish tasks Ability to interpret study level data & translate and identify risks Ability to proactively identify & mitigate risks around study execution Country level cultural awareness and strong interpersonal skills Keen problem solving skills Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management) Excellent communication skills, both written and verbal. Must be fluent in English. Additional Details: Eligible for Employee Referral Bonus Can be remote based Pfizer US/PR Exempt Grade 12 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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