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inVentiv Health
Global Trial Lead
Position Includes Medical Benefits and Paid Time Off
Top 10 Pharmaceutical Company in Collegeville PA is seeking a Global Trial Lead to join their team.
Global Study Leader will have ultimate responsibility and accountability for study execution. The GTL will need collaborate and coordinate cross-functionally and cross-regionally to execute the study, when taking corrective action to address major study level issues, and when making major study and site level decisions. The GTL will likely sit across multiple studies and may span a program as the trial leader as program size and associated workload allows.
JOB RESPONSIBILITIES
1. Plan, manage and execute study 35%
- Ensure regulatory compliance and GCP adherence at the study level
- Take corrective action for major study level issues (e.g. enrollment lagging across
several regions)
- Make major site level decisions (e.g. final site selection) based on input from the
team
- Plan, facilitate, and lead study team meetings
- Provide direct input into the protocol writing process on operational aspects
- Accountable for protocol execution across a study
- Provide input during budget creation to GCPL
- Manages budget during study execution
- Creates and drives study level timelines
- Develops study level enrollment plan
2. Coordinate with functional areas, operation specialists, and regions for input on study 25%
management - Study start up through database freeze
- Manages and oversees resolution of study level issues
- Plans and facilitates ADD process and meetings
- Accountable for vendor selection across study with appropriate study team consultation
- Facilitate communication to the regions
- Ensure training of RSMs
- GMM/CS develop RSM, Site Manager and Site medical training materials
- GTL develops operational training materials for the RSM, Site Manager, and Site
- Collect and report study status for enrollment, data entry, study materials and other study
status across regions
- Collaborate with Drug Supply and CPD and RSMs to coordinate test article and non-drug supplies across regions
3. Ensure standard processes, tools, and procedures used consistently and globally 15%
- Plans, drives, and facilitates investigator meeting
- Generates operational study level training materials
- Direct global coordination
- Manage and guide study team cohesion
- Push protocol changes or amendments to regions
4. Coordinate / write monitoring plan for entire study, across all regions 10%
- Ensure Regional Study Managers input for individual regions
- Ensure medical input in consultation with the Clinical Scientist
- Drive study timeline across all regions
- Execute global study management
- End timelines tracking
5. Interact with regulatory organizations at the study level 5%
- Accountable and responsible for coordinating all audit responses at the study level
6. Coordinate with BDPM to assure data capture and cleaning is acceptable with study timelines 5%
cross regions (e.g. track missing pages, outstanding queries, and drive the process to ensure
timely resolution)
7. Facilitate study close out activities 5%
- Ensure complete close out of all sites
- Ensure completion of final drug accountability
- Ensure audit readiness
Total 100%
WORK FLOW
The GTL is assigned a study by the GTL line management after the "Protocol Go" decision. The GTL will facilitate study team meetings and interaction throughout study. GTL is accountable and responsible for successful execution of the study. The GTL interacts with the GCPL for project level issues and to ensure coordination and alignment with the program.
DECISION MAKING
A. Describe the decisions generally made and indicate whether the incumbent is the final authority or participates in the decisions.
- Decisions made to ensure operation feasibility of a protocol
- Vendor Selection
- Makes decisions that affect study execution and issue resolution during clinical trial conduct.
B. Describe the effect the decisions can have on company programs, processes, services, customers or financial results.
The GTL makes study level decisions which could have a high level of impact on programs and financial results. Decisions affecting enrollment, compliance oversight, study budget, and issue resolution could adversely or positively affect the outcome of the study/program and ultimately affect the financial results. Investigator's also have the potential to be positively or negatively impacted by decisions made by the GTL.
C. Outline the guidelines, practices, or limits which are used in making decisions and which assist in recognizing the limits of authority.
- Guidelines for conducting clinical trials are based on FDA and other BoH published regulations of Good Clinical Practice.
- SOPs govern the implementation clinical studies.
-Major study level decisions affecting the overall program will be made in consultation with the GCPL.
SUPERVISION
The Global Trial Leader will be supervised by GTL line management. The GTL will also receive performance input and program level guidance from the GCPL. GTL is works independently for simple tasks, with some supervision for moderately complex tasks and with supervision for complex tasks.
BUDGETASSET RESPONSIBILIT
A. Describe the duties that relate to budget preparation.
- The GTL will manage and track study budget across regions according to identified timelines.
B. What is the value of the budget or assets administered in terms of $ or units, or end results?
- Will vary from several $100,000 to $20MM or more.
VII. INTERPERSONAL CONTACTS
A. Internal Contacts
a) Global Medical Monitor - Study Team Interaction - Often-As needed
b) Clinical Scientists - Study Team Interaction - Often-As needed
c) Regional Study Manager - Study Team Interaction - Often-As needed
d) Operations Specialists - Study task assignment and follow up completion of tasks - Often-As needed
e) GCPL - Project to program level coordination and project level guidance - As needed
B. External Contacts
a) Central IRB - Study Level Issues - Study Start up/Ongoing when AEs occur
b) Regulatory Agencies - Audit Response - Audit only
INGENUITY
Describe typical job situations that require creativity and innovation.
Study and escalated site level issue resolution and coordinating cross-culturally/ regionally will require ingenuity. Providing operational advice to protocol development will require innovation due to the uniqueness of each protocol. Operational and medical coordination and collaboration will need creativity to ensure study success.
Independently solves simple to moderate problems and looks for areas to improve and makes suggestion with CTO or TA.
Long Term: GTLs create the overall timeline and monitoring plan for the study, specifying FPFV, Planned Enrollment, clean data points tracking, LPLV, and target DB freeze.
Short Term:
ADD Planning
Inv. Mtg Planning
Training materials and plan for RSM / SMs
TRAINING AND EXPERIENCE
1. What formal education is required to perform the job duties (Degree, field)?
- BS Degree in Health / Science preferred, non-relevant degree accepted with relevant experience
Apply:
For faster processing, please apply online and directly to the employer. Specific instructions on how to apply are available. (recommended)
Global Trial Lead
Position Includes Medical Benefits and Paid Time Off
Top 10 Pharmaceutical Company in Collegeville PA is seeking a Global Trial Lead to join their team.
Global Study Leader will have ultimate responsibility and accountability for study execution. The GTL will need collaborate and coordinate cross-functionally and cross-regionally to execute the study, when taking corrective action to address major study level issues, and when making major study and site level decisions. The GTL will likely sit across multiple studies and may span a program as the trial leader as program size and associated workload allows.
JOB RESPONSIBILITIES
1. Plan, manage and execute study 35%
- Ensure regulatory compliance and GCP adherence at the study level
- Take corrective action for major study level issues (e.g. enrollment lagging across
several regions)
- Make major site level decisions (e.g. final site selection) based on input from the
team
- Plan, facilitate, and lead study team meetings
- Provide direct input into the protocol writing process on operational aspects
- Accountable for protocol execution across a study
- Provide input during budget creation to GCPL
- Manages budget during study execution
- Creates and drives study level timelines
- Develops study level enrollment plan
2. Coordinate with functional areas, operation specialists, and regions for input on study 25%
management - Study start up through database freeze
- Manages and oversees resolution of study level issues
- Plans and facilitates ADD process and meetings
- Accountable for vendor selection across study with appropriate study team consultation
- Facilitate communication to the regions
- Ensure training of RSMs
- GMM/CS develop RSM, Site Manager and Site medical training materials
- GTL develops operational training materials for the RSM, Site Manager, and Site
- Collect and report study status for enrollment, data entry, study materials and other study
status across regions
- Collaborate with Drug Supply and CPD and RSMs to coordinate test article and non-drug supplies across regions
3. Ensure standard processes, tools, and procedures used consistently and globally 15%
- Plans, drives, and facilitates investigator meeting
- Generates operational study level training materials
- Direct global coordination
- Manage and guide study team cohesion
- Push protocol changes or amendments to regions
4. Coordinate / write monitoring plan for entire study, across all regions 10%
- Ensure Regional Study Managers input for individual regions
- Ensure medical input in consultation with the Clinical Scientist
- Drive study timeline across all regions
- Execute global study management
- End timelines tracking
5. Interact with regulatory organizations at the study level 5%
- Accountable and responsible for coordinating all audit responses at the study level
6. Coordinate with BDPM to assure data capture and cleaning is acceptable with study timelines 5%
cross regions (e.g. track missing pages, outstanding queries, and drive the process to ensure
timely resolution)
7. Facilitate study close out activities 5%
- Ensure complete close out of all sites
- Ensure completion of final drug accountability
- Ensure audit readiness
Total 100%
WORK FLOW
The GTL is assigned a study by the GTL line management after the "Protocol Go" decision. The GTL will facilitate study team meetings and interaction throughout study. GTL is accountable and responsible for successful execution of the study. The GTL interacts with the GCPL for project level issues and to ensure coordination and alignment with the program.
DECISION MAKING
A. Describe the decisions generally made and indicate whether the incumbent is the final authority or participates in the decisions.
- Decisions made to ensure operation feasibility of a protocol
- Vendor Selection
- Makes decisions that affect study execution and issue resolution during clinical trial conduct.
B. Describe the effect the decisions can have on company programs, processes, services, customers or financial results.
The GTL makes study level decisions which could have a high level of impact on programs and financial results. Decisions affecting enrollment, compliance oversight, study budget, and issue resolution could adversely or positively affect the outcome of the study/program and ultimately affect the financial results. Investigator's also have the potential to be positively or negatively impacted by decisions made by the GTL.
C. Outline the guidelines, practices, or limits which are used in making decisions and which assist in recognizing the limits of authority.
- Guidelines for conducting clinical trials are based on FDA and other BoH published regulations of Good Clinical Practice.
- SOPs govern the implementation clinical studies.
-Major study level decisions affecting the overall program will be made in consultation with the GCPL.
SUPERVISION
The Global Trial Leader will be supervised by GTL line management. The GTL will also receive performance input and program level guidance from the GCPL. GTL is works independently for simple tasks, with some supervision for moderately complex tasks and with supervision for complex tasks.
BUDGETASSET RESPONSIBILIT
A. Describe the duties that relate to budget preparation.
- The GTL will manage and track study budget across regions according to identified timelines.
B. What is the value of the budget or assets administered in terms of $ or units, or end results?
- Will vary from several $100,000 to $20MM or more.
VII. INTERPERSONAL CONTACTS
A. Internal Contacts
a) Global Medical Monitor - Study Team Interaction - Often-As needed
b) Clinical Scientists - Study Team Interaction - Often-As needed
c) Regional Study Manager - Study Team Interaction - Often-As needed
d) Operations Specialists - Study task assignment and follow up completion of tasks - Often-As needed
e) GCPL - Project to program level coordination and project level guidance - As needed
B. External Contacts
a) Central IRB - Study Level Issues - Study Start up/Ongoing when AEs occur
b) Regulatory Agencies - Audit Response - Audit only
INGENUITY
Describe typical job situations that require creativity and innovation.
Study and escalated site level issue resolution and coordinating cross-culturally/ regionally will require ingenuity. Providing operational advice to protocol development will require innovation due to the uniqueness of each protocol. Operational and medical coordination and collaboration will need creativity to ensure study success.
Independently solves simple to moderate problems and looks for areas to improve and makes suggestion with CTO or TA.
Long Term: GTLs create the overall timeline and monitoring plan for the study, specifying FPFV, Planned Enrollment, clean data points tracking, LPLV, and target DB freeze.
Short Term:
ADD Planning
Inv. Mtg Planning
Training materials and plan for RSM / SMs
TRAINING AND EXPERIENCE
1. What formal education is required to perform the job duties (Degree, field)?
- BS Degree in Health / Science preferred, non-relevant degree accepted with relevant experience
Apply:
For faster processing, please apply online and directly to the employer. Specific instructions on how to apply are available. (recommended)
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