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est. per hour
Clinical Operations Study Team Lead -- Oncology (Director) - Full-time / Part-time
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Cambridge, Massachusetts |
About this job
Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Role Description
The Clinical Operations Study Team Lead (Study Team Lead) delivers on Pfizer's commitment to develop new medicines by leading internal (Dev Ops) and/or external (Alliance Partner/Vendor/Contractors) operational resources to ensure that overall study timeline, cost and quality goals are met. The Study Team Lead is an expert on the operational delivery of clinical studies and brings that expertise to the design and conduct of clinical development at Pfizer. The
Study Team Lead is accountable for the operational delivery of one or more clinical studies from study concept through reporting, submission and regulatory defense within one or more development projects. The Study Team Lead is responsible for operational oversight of all study activities and escalates issues when needed. The Study Team Lead provides joint leadership (in partnership with the Clinician) of the study team and ensures good team functioning.
Responsibilities
* Provides Study Team Leadership
* Serves as co-lead (with Clinician) of study team and leads the Clinical Operations subteam
* Ensures cross-functional connectivity among team members and supporting functional lines
* Manages study team meetings and facilitates effective decision making
* Fosters synergistic team health and engagement.
* Supports Practical Clinical Study Design
* Partners with Clinician and other team members and supporting functional lines to provide operational expertise and insight to inform protocol design.
* Initiates and ensures a Protocol Operational Feasibility and Budget assessment is performed by seeking input from other lines within Development Operations and at the Alliance Partner/Vendor as needed.
* Facilitates early engagement of Alliance Partners/Vendors when needed.
* Provides Operational Oversight -- Accountable for the operational success of the study.
* Serves as primary Development Operations point of contact for the study. Engages early within project team to ensure effective up-front planning
* Develops accurate study plans (timelines, budget) in concert with Alliance
* Partner/Outsourcing Provider and utilizing resources from Dev Ops Lines and aligning with RU/BU business needs.
* Provides critical assessment of AP and 3rd party vendor proposals. Pressure tests planning and resourcing assumptions to ensure success.
* Oversees Site Feasibility and Site Selection Process in partnership with Clinical Trial
* Execution Center of Excellence (Named COL, Global Site Start Up Unit) and Alliance
* Partner/Vendor
* Maintains collaborative working relationship with AP/CRO to provide appropriate level of AP/vendor oversight to ensure study success. Assists in issue resolution and escalation when needed.
* Oversee and ensure appropriate and quality interactions between the site/investigators and CRO/Vendor related to the conduct of a clinical study.
* Works proactively with AP/CRO and Pfizer internal functions to ensure timely delivery of data.
* Leads Quality/Risk Management Activities -- Proactively identifies risks to delivery or quality and ensures that appropriate risk mitigation plans are in place.
* Oversees the study risk planning process (e.g. IQMP)
* Communicates opportunities and risks to the RU/BU and Dev Ops project leadership. Ensures cross functional buy-in to risk mitigation plans.
* Ensures compliance with all applicable SOPs and Quality Standards
* Raises quality issues when required.
* Coordinates and oversees inspection readiness activities including maintenance of study documentation.
* Provides Cross Pfizer Coordination -- Provides guidance on availability of expertise on Pfizer processes and systems with access to Pfizer subject matter experts to support AP/CRO tasks and issue resolution.
* Provides Financial Oversight -- Forecasts and manages high level clinical trial budget and supports invoicing approvals as needed and dependent on current process.
Qualifications
Education and Experience:
* Experience in Oncology
* Prior Pfizer experience (preferred)
* Prior regulatory submission and inspection experience (preferred)
* B.A./B.S. or equivalent required
* 10-15 years of Clinical Development experience
* At least 5 years of direct project management experience required
* Experience managing CRO staff to deliver clinical studies
Technical Skills:
* Thorough understanding of good clinical practices (GCP)
* Thorough understanding of key operational elements of clinical research (e.g., site selection, monitoring, data acquisition and cleaning, reporting, etc.)
* Develops and maintains relevant scientific knowledge within assigned program and or asset
* Ability to participate and support sponsor regulatory interactions/inspections
* Protocol design and operational feasibility assessment
* Matrix team leadership
* Vendor management
* Strong knowledge in disease and technical areas pertaining to clinical studies
* Effective leadership, project management, influencing, negotiating, problem solving, analytical, verbal, and written communications skills required to ensure executable study design and operational alignment
* Strong networking & relationship building skills
* Ability to identify, analyze, and manage risk
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.
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Role Description
The Clinical Operations Study Team Lead (Study Team Lead) delivers on Pfizer's commitment to develop new medicines by leading internal (Dev Ops) and/or external (Alliance Partner/Vendor/Contractors) operational resources to ensure that overall study timeline, cost and quality goals are met. The Study Team Lead is an expert on the operational delivery of clinical studies and brings that expertise to the design and conduct of clinical development at Pfizer. The
Study Team Lead is accountable for the operational delivery of one or more clinical studies from study concept through reporting, submission and regulatory defense within one or more development projects. The Study Team Lead is responsible for operational oversight of all study activities and escalates issues when needed. The Study Team Lead provides joint leadership (in partnership with the Clinician) of the study team and ensures good team functioning.
Responsibilities
* Provides Study Team Leadership
* Serves as co-lead (with Clinician) of study team and leads the Clinical Operations subteam
* Ensures cross-functional connectivity among team members and supporting functional lines
* Manages study team meetings and facilitates effective decision making
* Fosters synergistic team health and engagement.
* Supports Practical Clinical Study Design
* Partners with Clinician and other team members and supporting functional lines to provide operational expertise and insight to inform protocol design.
* Initiates and ensures a Protocol Operational Feasibility and Budget assessment is performed by seeking input from other lines within Development Operations and at the Alliance Partner/Vendor as needed.
* Facilitates early engagement of Alliance Partners/Vendors when needed.
* Provides Operational Oversight -- Accountable for the operational success of the study.
* Serves as primary Development Operations point of contact for the study. Engages early within project team to ensure effective up-front planning
* Develops accurate study plans (timelines, budget) in concert with Alliance
* Partner/Outsourcing Provider and utilizing resources from Dev Ops Lines and aligning with RU/BU business needs.
* Provides critical assessment of AP and 3rd party vendor proposals. Pressure tests planning and resourcing assumptions to ensure success.
* Oversees Site Feasibility and Site Selection Process in partnership with Clinical Trial
* Execution Center of Excellence (Named COL, Global Site Start Up Unit) and Alliance
* Partner/Vendor
* Maintains collaborative working relationship with AP/CRO to provide appropriate level of AP/vendor oversight to ensure study success. Assists in issue resolution and escalation when needed.
* Oversee and ensure appropriate and quality interactions between the site/investigators and CRO/Vendor related to the conduct of a clinical study.
* Works proactively with AP/CRO and Pfizer internal functions to ensure timely delivery of data.
* Leads Quality/Risk Management Activities -- Proactively identifies risks to delivery or quality and ensures that appropriate risk mitigation plans are in place.
* Oversees the study risk planning process (e.g. IQMP)
* Communicates opportunities and risks to the RU/BU and Dev Ops project leadership. Ensures cross functional buy-in to risk mitigation plans.
* Ensures compliance with all applicable SOPs and Quality Standards
* Raises quality issues when required.
* Coordinates and oversees inspection readiness activities including maintenance of study documentation.
* Provides Cross Pfizer Coordination -- Provides guidance on availability of expertise on Pfizer processes and systems with access to Pfizer subject matter experts to support AP/CRO tasks and issue resolution.
* Provides Financial Oversight -- Forecasts and manages high level clinical trial budget and supports invoicing approvals as needed and dependent on current process.
Qualifications
Education and Experience:
* Experience in Oncology
* Prior Pfizer experience (preferred)
* Prior regulatory submission and inspection experience (preferred)
* B.A./B.S. or equivalent required
* 10-15 years of Clinical Development experience
* At least 5 years of direct project management experience required
* Experience managing CRO staff to deliver clinical studies
Technical Skills:
* Thorough understanding of good clinical practices (GCP)
* Thorough understanding of key operational elements of clinical research (e.g., site selection, monitoring, data acquisition and cleaning, reporting, etc.)
* Develops and maintains relevant scientific knowledge within assigned program and or asset
* Ability to participate and support sponsor regulatory interactions/inspections
* Protocol design and operational feasibility assessment
* Matrix team leadership
* Vendor management
* Strong knowledge in disease and technical areas pertaining to clinical studies
* Effective leadership, project management, influencing, negotiating, problem solving, analytical, verbal, and written communications skills required to ensure executable study design and operational alignment
* Strong networking & relationship building skills
* Ability to identify, analyze, and manage risk
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.
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