Clinical Trial Manager/Project Manager; US-East-Coast Remote
Position: Clinical Trial Manager/Project Manager (US-East-Coast Remote)
Location: California
Clinical Trial Manager/Project Manager (US-East-Coast Remote)
Job Openings Clinical Trial Manager/Project Manager (US-East-Coast Remote)
About the job Clinical Trial Manager/Project Manager (US-East-Coast Remote) Responsibilities
The Clinical Trial Manager (CTM) is accountable for achieving successful delivery of clinical activities at the project level by meeting internal and external contractually agreed client and regulatory requirements according to time, quality/scope and budget constraints. The Clinical Trial Manager (CTM) leads and directs cross functional teams and understands/manages client expectations. In addition, the Clinical Trial Manager (CTM) proactively identifies, resolves/mitigates and escalates risks and/or issues.
Depending on the business unit the descripted accountabilities may or may not apply.
• Daily Management of a Trials
• POC for sponsor, sites and CRAs
• Study Tracking and Monitoring trip report review
Provides Project Oversight and Leadership for Clinical Deliverables:
Leads and manages the start-up and clinical teams
Plans and leads execution of the day to day activities for the monitoring of a clinical study
and communicates consistently with the clinical team providing project objectives, expectations and
status updates. Works with the team to set priorities
Takes the initiative to make things happen and leads and supports the relevant staff ( this may
include but is not limited by Country Start Up Specialist (CSS), Global Regulatory Affairs Lead
(GRAL), Local Regulatory Affairs Lead (LRAL) and In-House Clinical Research Associate (IHCRA)) to
ensure the successful activation of trial sites according to time, quality/scope and budget
parameters
Motivates the clinical team
Ensures effective communication plans are place for the clinical team Ensures effective escalation
plans are in place for the clinical team
Works with the Project Manager (PM) to facilitate cross functional team and sponsor communication
for proactive, study-wide problem solving regarding study progress and trial issues during the
study
Monitors the quality of clinical deliverables and addresses quality issues with the appropriate
team member
Oversees the GRAL, LRAL and IHCRA to ensure that all non-safety periodic updates, progress reports and
renewals and/or end of study notifications are performed in accordance with the trial protocol, local regulations,
ICH-GCP and any other processes or procedures governing the clinical trial.
Identifies metrics and trends across team members, countries, regions and uses the information to
promote improvement in quality and consistency of execution.
Collaborates with Quality Assurance (QA) to identify sites needing corrective and preventative action plans,
responds completely and accurately to audit reports, provides team with project-specific audit process to ensure
adequate preparations/reviews of all audit responses prior to submission to internal clinical review team/QA and
then Sponsor Organizes project specific compliance plans for key processes, tools and systems
Reviews filing of Essential Documents in the electronic Trial Master File to ensure sponsor and investigator
obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines
Project Finance
Provides Time Entry Guidelines to the relevant study team members in adherence with project scope and budget;
monitor burn rates, escalating issues with potential solutions to the Project Manager (PM).
Forecasts units and hours and generic resources for the start-up and monitoring activities, determines worked units
and hours, analyzing forecasted and worked activities to ensure adherence to contract and budget
Ensures that forecasted units are achieved as planned and within the budgeted FTE
Identifies out-of-scope tasks from clinical team and escalates as required
Ensures no out-scope tasks be conducted without the required evidence of agreement from the client or approval
by the relevant PRA staff.
Customer Relations (Internal & External)
Interfaces with other Functional Leads, vendors and client as required to ensure clinical monitoring outcomes are
achieved
Serves as primary liaison for clinical monitoring issues, interacting with clients, vendors and other PRA functional
areas, escalating as required
Participates in client meetings, assisting with presentations as required
Contributes to Business Development activities
Qualifications
Education:
• Bachelors Degree in health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.
Experince requried:
• 2+ years of clinical research project management experience required
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Apply Now
Apply Now
Location: California
Clinical Trial Manager/Project Manager (US-East-Coast Remote)
Job Openings Clinical Trial Manager/Project Manager (US-East-Coast Remote)
About the job Clinical Trial Manager/Project Manager (US-East-Coast Remote) Responsibilities
The Clinical Trial Manager (CTM) is accountable for achieving successful delivery of clinical activities at the project level by meeting internal and external contractually agreed client and regulatory requirements according to time, quality/scope and budget constraints. The Clinical Trial Manager (CTM) leads and directs cross functional teams and understands/manages client expectations. In addition, the Clinical Trial Manager (CTM) proactively identifies, resolves/mitigates and escalates risks and/or issues.
Depending on the business unit the descripted accountabilities may or may not apply.
• Daily Management of a Trials
• POC for sponsor, sites and CRAs
• Study Tracking and Monitoring trip report review
Provides Project Oversight and Leadership for Clinical Deliverables:
Leads and manages the start-up and clinical teams
Plans and leads execution of the day to day activities for the monitoring of a clinical study
and communicates consistently with the clinical team providing project objectives, expectations and
status updates. Works with the team to set priorities
Takes the initiative to make things happen and leads and supports the relevant staff ( this may
include but is not limited by Country Start Up Specialist (CSS), Global Regulatory Affairs Lead
(GRAL), Local Regulatory Affairs Lead (LRAL) and In-House Clinical Research Associate (IHCRA)) to
ensure the successful activation of trial sites according to time, quality/scope and budget
parameters
Motivates the clinical team
Ensures effective communication plans are place for the clinical team Ensures effective escalation
plans are in place for the clinical team
Works with the Project Manager (PM) to facilitate cross functional team and sponsor communication
for proactive, study-wide problem solving regarding study progress and trial issues during the
study
Monitors the quality of clinical deliverables and addresses quality issues with the appropriate
team member
Oversees the GRAL, LRAL and IHCRA to ensure that all non-safety periodic updates, progress reports and
renewals and/or end of study notifications are performed in accordance with the trial protocol, local regulations,
ICH-GCP and any other processes or procedures governing the clinical trial.
Identifies metrics and trends across team members, countries, regions and uses the information to
promote improvement in quality and consistency of execution.
Collaborates with Quality Assurance (QA) to identify sites needing corrective and preventative action plans,
responds completely and accurately to audit reports, provides team with project-specific audit process to ensure
adequate preparations/reviews of all audit responses prior to submission to internal clinical review team/QA and
then Sponsor Organizes project specific compliance plans for key processes, tools and systems
Reviews filing of Essential Documents in the electronic Trial Master File to ensure sponsor and investigator
obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines
Project Finance
Provides Time Entry Guidelines to the relevant study team members in adherence with project scope and budget;
monitor burn rates, escalating issues with potential solutions to the Project Manager (PM).
Forecasts units and hours and generic resources for the start-up and monitoring activities, determines worked units
and hours, analyzing forecasted and worked activities to ensure adherence to contract and budget
Ensures that forecasted units are achieved as planned and within the budgeted FTE
Identifies out-of-scope tasks from clinical team and escalates as required
Ensures no out-scope tasks be conducted without the required evidence of agreement from the client or approval
by the relevant PRA staff.
Customer Relations (Internal & External)
Interfaces with other Functional Leads, vendors and client as required to ensure clinical monitoring outcomes are
achieved
Serves as primary liaison for clinical monitoring issues, interacting with clients, vendors and other PRA functional
areas, escalating as required
Participates in client meetings, assisting with presentations as required
Contributes to Business Development activities
Qualifications
Education:
• Bachelors Degree in health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.
Experince requried:
• 2+ years of clinical research project management experience required
#J-18808-Ljbffr
Apply Now
Apply Now