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Clinical Operations Study Manager
Eingestellt von Synectics
Gesuchte Skills: Design, Support
Projektbeschreibung
Delivers on the company'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 Manager is an expert on the operational delivery of clinical trials and brings that expertise to the design and conduct of clinical development. The Manager 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 Manager is responsible for operational oversight of all study activities and escalates issues when needed. The Manager provides joint leadership (in partnership with the Clinician of the study team and ensures good team functioning.
POSITION RESPONSIBILITIES
Provides Study Team Leadership - o Serves as co-lead (with Clinician) of study team and leads the Clinical Operations sub-team.
o Ensures cross-functional connectivity among team members and supporting functional lines
o Manages study team meetings and facilitates effective decision making
o Fosters synergistic team health and engagement.
Supports Practical Clinical Trial Design
o Partners with Clinician and other team members and supporting functional lines to provide operational expertise and insight to inform protocol design.
o Initiates and ensures a Protocol Operational Feasibility assessment is performed by seeking input from other lines within Development Operations and at the Alliance Partner/Vendor as needed.
o Facilitates early engagement of Alliance Partners/Vendors when needed.
Provides Operational Oversight - Accountable for the operational success of the study.
o Serves as primary Dev Ops point of contact for the study. Engages early within project team to ensure effective up-front planning
o Develops accurate study plans (timelines, budget) in concert with Alliance Partner/Outsourcing Provider and utilizing resources from Dev Ops Lines and aligning with business needs.
o Provides critical assessment of AP and 3rd party vendor proposals. Pressure tests planning and resourcing assumptions to ensure success.
o Oversees Site Feasibility and Site Selection Process
o Maintains collaborative working relationship to provide appropriate level of AP/vendor oversight to ensure study success. Assists in issue resolution and escalation when needed.
o Ensures and enhances investigator/site relationships.
o Works proactively with Company 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.
o Oversees the study risk planning process
o Communicates opportunities and risks to the Dev Ops project leadership. Ensures cross functional buy-in to risk mitigation plans.
o Ensures compliance with all applicable SOPs and Quality Standards
o Raises quality issues when required.
o Coordinates and oversees inspection readiness activities including maintenance of study documentation.
Provides Cross Coordination - Provides guidance on availability of expertise on processes and systems with access to subject matter experts to support tasks and issue resolution.
Provides Financial Oversight - Forecasts and manages high level clinical trial budget.
RESOURCES MANAGED
Financial Accountability
Maintains high level accountability for the Clinical Trial Budget ($500k - $20M)
SUPERVISION
Individual contributor - No direct reports managed
Matrixed Leader for Core Team of 5 to 10 Colleagues
SKILLS:
EDUCATION AND EXPERIENCE
B.A./B.S. or equivalent required
5 years of Clinical Development experience;
At least 2 years of direct project and/or study management experience required
Experience managing staff to deliver clinical studies
TECHNICAL SKILLS REQUIREMENTS
Thorough understanding of good clinical practices (GCP)
Thorough understanding of key operational elements of clinical research (eg, site selection, monitoring, data acquisition and cleaning, reporting, etc)
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 trials
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
TOP SKILLS MANAGER IS LOOKING FOR
1- LEADERSHIP SKILLS
2 - Some that has worked in a large Matrix environment with competing priorities.
3 - Large Cardiovascular endpoint studies
4 - Clinical Trial Study Management experience
5 - Someone that has worked on the CRO (Clinical Research org) side, or the Sponsor side.
6 - Good Manufacturing Practices (GMP)
International Travel Required
POSITION RESPONSIBILITIES
Provides Study Team Leadership - o Serves as co-lead (with Clinician) of study team and leads the Clinical Operations sub-team.
o Ensures cross-functional connectivity among team members and supporting functional lines
o Manages study team meetings and facilitates effective decision making
o Fosters synergistic team health and engagement.
Supports Practical Clinical Trial Design
o Partners with Clinician and other team members and supporting functional lines to provide operational expertise and insight to inform protocol design.
o Initiates and ensures a Protocol Operational Feasibility assessment is performed by seeking input from other lines within Development Operations and at the Alliance Partner/Vendor as needed.
o Facilitates early engagement of Alliance Partners/Vendors when needed.
Provides Operational Oversight - Accountable for the operational success of the study.
o Serves as primary Dev Ops point of contact for the study. Engages early within project team to ensure effective up-front planning
o Develops accurate study plans (timelines, budget) in concert with Alliance Partner/Outsourcing Provider and utilizing resources from Dev Ops Lines and aligning with business needs.
o Provides critical assessment of AP and 3rd party vendor proposals. Pressure tests planning and resourcing assumptions to ensure success.
o Oversees Site Feasibility and Site Selection Process
o Maintains collaborative working relationship to provide appropriate level of AP/vendor oversight to ensure study success. Assists in issue resolution and escalation when needed.
o Ensures and enhances investigator/site relationships.
o Works proactively with Company 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.
o Oversees the study risk planning process
o Communicates opportunities and risks to the Dev Ops project leadership. Ensures cross functional buy-in to risk mitigation plans.
o Ensures compliance with all applicable SOPs and Quality Standards
o Raises quality issues when required.
o Coordinates and oversees inspection readiness activities including maintenance of study documentation.
Provides Cross Coordination - Provides guidance on availability of expertise on processes and systems with access to subject matter experts to support tasks and issue resolution.
Provides Financial Oversight - Forecasts and manages high level clinical trial budget.
RESOURCES MANAGED
Financial Accountability
Maintains high level accountability for the Clinical Trial Budget ($500k - $20M)
SUPERVISION
Individual contributor - No direct reports managed
Matrixed Leader for Core Team of 5 to 10 Colleagues
SKILLS:
EDUCATION AND EXPERIENCE
B.A./B.S. or equivalent required
5 years of Clinical Development experience;
At least 2 years of direct project and/or study management experience required
Experience managing staff to deliver clinical studies
TECHNICAL SKILLS REQUIREMENTS
Thorough understanding of good clinical practices (GCP)
Thorough understanding of key operational elements of clinical research (eg, site selection, monitoring, data acquisition and cleaning, reporting, etc)
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 trials
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
TOP SKILLS MANAGER IS LOOKING FOR
1- LEADERSHIP SKILLS
2 - Some that has worked in a large Matrix environment with competing priorities.
3 - Large Cardiovascular endpoint studies
4 - Clinical Trial Study Management experience
5 - Someone that has worked on the CRO (Clinical Research org) side, or the Sponsor side.
6 - Good Manufacturing Practices (GMP)
International Travel Required
Projektdetails
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Einsatzort:
New York, Vereinigte Staaten
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Projektbeginn:
asap
-
Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges