Posted:
9/20/2024, 12:28:00 AM
Location(s):
Massachusetts, United States
Experience Level(s):
Senior
Field(s):
Operations & Logistics
Workplace Type:
Remote
The Director of Site Management and Monitoring (DSMM), in partnership with the Director of Clinical Site Operations (DCSO) is accountable for ensuring appropriate Site Care Partner (SCP), as well as Site Monitor resources are in place to deliver on, country and site-level end to end study start up, management and monitoring activities in-line with study milestones in the designated countries/clusters/regions, as well as providing line management and overseeing the job function of the Site Care Partner and Site Monitor.
The Director of Site Management and Monitoring supports the DCSO, who is accountable to ensure overall monitoring, operational site management and oversight activities within a designated country/cluster/region and supervises the monitoring, oversight activities of sites to ensure patient safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Pfizer standards.
This role partners cross functionally with others in Study Start Up (Start Up Project Management (SUPM), Site Activation Partner (SAP), Clinical Trial Assistant (CTA), Investigator Contracts Lead (ICL)), Optimization, Analytics, and Recruitment Solutions (OARS), Patient Recruitment and Study Management to provide input to country and site selection and collaborate with country regulatory/regional Clinical Trial Regulatory Operations (CTRO) to facilitate Clinical Trial Application/IRB/EC approval for allocated studies in their cluster when applicable. The role also executes investigator site/recruitment strategies and site-level end to end study start up, management and monitoring activities.
The Director of Site Management and Monitoring will lead, contribute to, and implement strategic initiatives as a representative of the GSSO Leadership. They will also lead initiatives that shape the clinical development environment within their country/cluster/region to facilitate Pfizer’s clinical development goals and scientific leadership. For example, this role actively manages risks and identifies opportunities for clinical trial conduct through engagement with local clinical development leaders and/or regulatory authorities, actively participates in local industry forums, builds portfolio-aligned, investigational sites/network relationships to shape performance of ethical clinical research, as needed (e.g., Decentralized Clinical Trial (DCT) readiness/ virtual monitoring, and drive the cycle times reduction).
The Director of Site Management and Monitoring provides insights on local/regional trends to facilitate the conduct of clinical trials and where appropriate is responsible for developing analyses and offering options for mitigation (both at the country/cluster and site level) on the trial’s conduct.
RESPONSIBILITIES:
Line Management of Site Care Partner roles and Site Monitors
Country/Cluster/Regional Environment & Across Site/Study Management (as delegated by the DCSO):
Relationship Management
Resource & Compliance Management
QUALIFICATIONS:
Education
Experience
Skills
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Minimal travel required
Work Location Assignment: Remote
#LI-REMOTE
#LI-PFE
The annual base salary for this position ranges from $149,200.00 to $248,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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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.
Website: https://www.pfizer.com/
Headquarter Location: New York, New York, United States
Employee Count: 10001+
Year Founded: 1849
IPO Status: Public
Last Funding Type: Post-IPO Debt
Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical ⋅ Precision Medicine