Responsibilities
The Clinical Trial Project Manager (CTPM) Associate leads the
cross-functional study team in the development and execution of
clinical trials and is accountable both regionally and globally to
deliver trial(s) with quality, on time, and within scope and budget.
The CTPM Associate leverages project management, regional operational
knowledge, clinical trial process leadership and expertise, and
scientific expertise to drive actions and coordinate efforts to
achieve or exceed these trial deliverables.
Primary Responsibilities: This job description is intended to provide
a general overview of the job requirements at the time it was
prepared. The job requirements of any position may change over time
and may include additional responsibilities not specifically described
in the job description. Consult with your supervision regarding your
actual job responsibilities and any related duties that may be
required for the position.
Project Management and Regional Operational Knowledge
? Use project management skills, processes and tools to develop and
execute local, regional and/or global clinical trials as described
below:
? Scope - Understand the scope of work required to complete the
clinical trial successfully. Monitor the status and make changes (per
change control process) as needed to meet the deliverables of the
trial.
? Timeline - Develop and track global trial enrollment plan by
gaining alignment and integrating inputs across functions and
geographies.
? Risk - Assess, identify and monitor trial-level risks. Incorporate
scientific knowledge, trial process, and regional expertise to create
one integrated trial-level risk mitigation and contingency plan.
? Budget - Understand the cross-functional, trial-level budget
components. Create and monitor the overall budget and assumptions
using financial tracking tools. Routinely network with appropriate
business partners, on trial-level budget status and changes.
? Partner with other organizations to coordinate and actively
participate in affiliate, site, and investigator training
? Drive and coordinate local, regional and global, cross-functional
study team throughout study implementation, execution, and closure,
empowering them to meet the clinical trial deliverables, including
issue management, contingency planning and issue resolution.
? Be accountable for trial/regional enrollment strategy and execution
starting from country allocation through Last Patient Entered
Treatment (LPET).
? Manage relationships and serve as a single point of contact and
central owner for trial communication to and from the Clinical
Development, CDDA, and Third Party Organization (TPOs).
? Apply problem-solving skills to daily issues with cross-functional
study team (including with vendors, affiliates/regions, global team
members and other business partners).
? Identify and assist in developing continuous improvement activities
based on important trends such as industry, regulatory, new
technology, etc.
? Manage TPO qualification process, selection, and oversight.
Clinical Trial Process Leadership and Expertise
? Demonstrate understanding of drug development process. Acknowledge
inter-relatedness of cross-functional activities and understand the
impact of project decisions on the overall clinical trial. Look for
opportunities to expand and deepen clinical trial process expertise.
? Be knowledgeable of the global and regional operating model;
coordinate and facilitate geographic and functional input to provide
to the study teams.
? Accountable for ensuring a state of inspection readiness of the TMF
records created, maintained, finalized, and owned by Clinical
Development
? Network and leverage expertise to anticipate trial and regional
issues, identify areas of process breakdown, assess situations and
propose proactive approaches that reduce and/or mitigate risks that
impact ability to deliver the clinical trial.
? Demonstrate ability to lead and influence in the midst of ambiguity
and coach peers, cross-functional team members and TPOs on aspects of
clinical trial process and regional specificities.
? Report, manage and interpret information for the clinical trial(s),
including completeness and accuracy across multiple business systems
and tools from study implementation through closure.
? Apply expertise and knowledge of global/regional regulations, Good
Clinical Practice (GCP) and standards of operation in the conduct of
clinical trials. Liaise with affiliates and other appropriate
resources to understand local regulatory requirements.\
Scientific Expertise
? Leverage scientific and regulatory knowledge to prepare and/or
provide technical consultation for clinical and regulatory documents,
prepare for meetings with regulatory agencies and draft responses to
questions from regulatory agencies, TPOs and affiliates.
? Combine scientific, regional, and operational knowledge as well as
process expertise to impact clinical trial design, feasibility and
implementation.
? Utilize clinical development knowledge, problem solving and
critical thinking skills to support the scientific needs of the
business.
Basic Qualifications
Bachelors or University degree (scientific or health-related field
preferred) or an advanced degree.
Additional Skills/Preferences
? Applied knowledge of project management methodology, processes and
tools
? Demonstrated ability to work cross-culturally with global
colleagues and with TPOs
? Ability to influence without authority
? Strong leadership and networking skills exhibited while working in
cross-functional and cross-cultural teams (internal & external) and on
projects
? Effective and influential communication, self-management, and
organizational skills
? Demonstrated ability to manage complex situations through
problem-solving, critical thinking and navigating ambiguity
? Flexibility to adjust to altered priorities
? Clinical trial experience with a strong working knowledge of the
clinical research process.
? Proficiency in use of project management tools and techniques
(e.g., Critical Chain, MS Project, MS, Excel, MS Powerpoint)
? Ability to travel periodically Associate Clinical Trial Project Manager
Responsibilities
The Clinical Trial Project Manager (CTPM) Associate leads the
cross-functional study team in the development and execution of
clinical trials and is accountable both regionally and globally to
deliver trial(s) with quality, on time, and within scope and budget.
The CTPM Associate leverages project management, regional operational
knowledge, clinical trial process leadership and expertise, and
scientific expertise to drive actions and coordinate efforts to
achieve or exceed these trial deliverables.
Primary Responsibilities: This job description is intended to provide
a general overview of the job requirements at the time it was
prepared. The job requirements of any position may change over time
and may include additional responsibilities not specifically described
in the job description. Consult with your supervision regarding your
actual job responsibilities and any related duties that may be
required for the position.
Project Management and Regional Operational Knowledge
? Use project management skills, processes and tools to develop and
execute local, regional and/or global clinical trials as described
below:
? Scope - Understand the scope of work required to complete the
clinical trial successfully. Monitor the status and make changes (per
change control process) as needed to meet the deliverables of the
trial.
? Timeline - Develop and track global trial enrollment plan by
gaining alignment and integrating inputs across functions and
geographies.
? Risk - Assess, identify and monitor trial-level risks. Incorporate
scientific knowledge, trial process, and regional expertise to create
one integrated trial-level risk mitigation and contingency plan.
? Budget - Understand the cross-functional, trial-level budget
components. Create and monitor the overall budget and assumptions
using financial tracking tools. Routinely network with appropriate
business partners, on trial-level budget status and changes.
? Partner with other organizations to coordinate and actively
participate in affiliate, site, and investigator training
? Drive and coordinate local, regional and global, cross-functional
study team throughout study implementation, execution, and closure,
empowering them to meet the clinical trial deliverables, including
issue management, contingency planning and issue resolution.
? Be accountable for trial/regional enrollment strategy and execution
starting from country allocation through Last Patient Entered
Treatment (LPET).
? Manage relationships and serve as a single point of contact and
central owner for trial communication to and from the Clinical
Development, CDDA, and Third Party Organization (TPOs).
? Apply problem-solving skills to daily issues with cross-functional
study team (including with vendors, affiliates/regions, global team
members and other business partners).
? Identify and assist in developing continuous improvement activities
based on important trends such as industry, regulatory, new
technology, etc.
? Manage TPO qualification process, selection, and oversight.
Clinical Trial Process Leadership and Expertise
? Demonstrate understanding of drug development process. Acknowledge
inter-relatedness of cross-functional activities and understand the
impact of project decisions on the overall clinical trial. Look for
opportunities to expand and deepen clinical trial process expertise.
? Be knowledgeable of the global and regional operating model;
coordinate and facilitate geographic and functional input to provide
to the study teams.
? Accountable for ensuring a state of inspection readiness of the TMF
records created, maintained, finalized, and owned by Clinical
Development
? Network and leverage expertise to anticipate trial and regional
issues, identify areas of process breakdown, assess situations and
propose proactive approaches that reduce and/or mitigate risks that
impact ability to deliver the clinical trial.
? Demonstrate ability to lead and influence in the midst of ambiguity
and coach peers, cross-functional team members and TPOs on aspects of
clinical trial process and regional specificities.
? Report, manage and interpret information for the clinical trial(s),
including completeness and accuracy across multiple business systems
and tools from study implementation through closure.
? Apply expertise and knowledge of global/regional regulations, Good
Clinical Practice (GCP) and standards of operation in the conduct of
clinical trials. Liaise with affiliates and other appropriate
resources to understand local regulatory requirements.\
Scientific Expertise
? Leverage scientific and regulatory knowledge to prepare and/or
provide technical consultation for clinical and regulatory documents,
prepare for meetings with regulatory agencies and draft responses to
questions from regulatory agencies, TPOs and affiliates.
? Combine scientific, regional, and operational knowledge as well as
process expertise to impact clinical trial design, feasibility and
implementation.
? Utilize clinical development knowledge, problem solving and
critical thinking skills to support the scientific needs of the
business.
Basic Qualifications
Bachelors or University degree (scientific or health-related field
preferred) or an advanced degree.
Additional Skills/Preferences
? Applied knowledge of project management methodology, processes and
tools
? Demonstrated ability to work cross-culturally with global
colleagues and with TPOs
? Ability to influence without authority
? Strong leadership and networking skills exhibited while working in
cross-functional and cross-cultural teams (internal & external) and on
projects
? Effective and influential communication, self-management, and
organizational skills
? Demonstrated ability to manage complex situations through
problem-solving, critical thinking and navigating ambiguity
? Flexibility to adjust to altered priorities
? Clinical trial experience with a strong working knowledge of the
clinical research process.
? Proficiency in use of project management tools and techniques
(e.g., Critical Chain, MS Project, MS, Excel, MS Powerpoint)
? Ability to travel periodically
We need : English (Good)
Type: Permanent
Payment:
Category: Others
