Associate Clinical Project Manager (ACPM)
Integrated Resources, Inc., Raleigh, NC, United States
Please note: in line with *** policy, this role is VDI only. *** will not be providing a laptop or equipment.
Primary Purpose / Regulatory Responsibilities
The Associate Clinical Project Manager (ACPM) provides comprehensive operational support to the CPM/Senior CPM/Lead CPM to deliver clinical studies from study protocol through study report and trial master file (TMF) archiving to ensure that timelines, quality and study objectives in accordance with the corporate objectives and *** Standard Operating Procedures (SOPs), International Council for Harmonization Good Clinical Practice (ICH GCP) and regulatory requirements are met. In addition, the ACPM supports the CPM/Senior CPM/Lead CPM by fostering the adoption of innovative practices at ***.
The ACPM collaborates closely with the CPM/Senior CPM/Lead CPM, who retains overall accountability for the study and determines which activities are delegated to the ACPM.
Key Responsibilities (may be delegated by the CPM/Senior CPM/Lead CPM to the ACPM)
Study Documentation Management
Maintain the trial master file (TMF) in an inspection-ready state to be complete, accurate, and legible through section reviews and oversight of cross-functional TMF responsibilities.
Participate in the review and finalization of clinical study-related documents and plans including, but not limited to, protocols, protocol amendments, informed consent form, clinical study reports (CSRs), regulatory submissions, IMP Handling Manual, TMF Plan, Study Management Plan and other study documents/plans as required.
Provide support for obtaining the Clinical Outcome Assessments (COA) and liaising with PCOR Lead, COM and other stakeholders under the supervision of the CPM/Senior CPM/Lead CPM.
Provide input into contracts, work orders and/or change orders and assist with review and management of invoice tracking/reconciliation.
Monitor clinical data collection to ensure data quality.
Project Communication
Manage stakeholder communications between internal teams and designated vendors.
Track study status and deliver updates and reports to stakeholders and senior management using *** and CRO metrics and systems.
Engage in efficient vendor and site coordination.
Participate in study-related meetings such as Study Team Meetings, Joint Clinical Study Team (JCST) meetings, Investigator Meetings, CRA workshops, and CRO training sessions.
Document team action items and decisions in accordance with the project communication plan.
Create and maintain the *** Study Team list, manage study SOP listings, and provide periodic updates.
Set up, maintain, and close study MS Teams channels and facilitate communication across these platforms, in collaboration with CROs as applicable.
Quality Management & Process Improvement
Support audit and inspection activities, ensuring readiness and timely resolution of findings in compliance with regulations (e.g., ICH GCP) and quality standards.
Assist with suspected serious breach assessments when applicable.
Contribute to process improvement initiatives, seeking efficiencies between *** and CRO systems (e.g., CTMS, TMF, Source Quality, SharePoint, Microsoft Teams), and share best practices with line managers, peers, and partner CROs.
Training Support
Develop and oversee study-specific training to ensure Study Team Members (STMs) adhere to protocol and study procedures.
Maintain the training matrix, including compliance tracking and development of training packages for Investigator Meetings, CSM trainings, and site initiation visits.
If delegated, oversee operational aspects of Investigator Meetings, collaborating with CROs, meeting planners, and vendors, and manage associated documentation and follow-up actions.
System Support
Set up studies in the *** Clinical Trial Management System (CTMS).
Conduct ongoing and final quality control checks in CTMS, liaising with CROs, CPMs, and CSOL (for iHome studies) to provide feedback and resolve issues.
Provide helpdesk support for clinical systems used by sites and sponsors.
Perform other study-related tasks assigned by the study team or CPM/Senior CPM/Lead CPM.
Education
Bachelor's degree
Competencies
An Associate Clinical Project Manager (ACPM) demonstrates an emerging-to-basic knowledge and application of technical and operational project management, interpersonal, and leadership competencies, which will include 1-2 years of CRA experience or similar and also the following:
General project management
Clinical project management
Operational clinical project management experience (phase 1 to phase 4 studies), including an understanding of the complexities of Global Clinical Development and Operations in
Early Phase Management Experience with Phase 1 or exploratory trials, often involving first-in-human studies and intensive safety monitoring.
Phase 2/3 Experience in pivotal trials that assess efficacy and safety at scale, often under regulatory scrutiny.
Late Phase and Post-Approval Study Management Involvement in realworld evidence generation, long-term safety follow-up, and market support studies. Includes NIS, PASS, and ISEG studies.
Technical ability (using *** systems and applications and proficiency in the Microsoft office suite)
Ability to interpret and use data and key performance indicators
Process and operational excellence
*** processes knowledge and process management
Languages: English: excellent written and oral.
Interpersonal
Self-Management & Personal Effectiveness
Organized and well-structured
Time management and planning
Self-awareness and self-regulation
Resilience
Sense of urgency with calm demeanor
Can-do attitude / proactivity / willing to learn and to develop
Relational Intelligence & Communication
Empathy
Listening
Conflict resolution
Clear and structured communication with appropriate escalation
Cultural awareness
Good presentation skills
Leadership
Driving Results & Accountability
Results and solution oriented
Ability to use circle of influence at all levels
Application of negotiation skills
SP Stakeholder Engagement
Customer focus and adaptability towards stakeholders
Effective networking
The ACPM represents *** professionally, aligning conduct with *** values, and possesses the knowledge and experience to perform tasks independently or under supervision, demonstrating desired behaviors within assigned projects and therapeutic areas.
(Competency level: Learn and Support)
#J-18808-Ljbffr
Primary Purpose / Regulatory Responsibilities
The Associate Clinical Project Manager (ACPM) provides comprehensive operational support to the CPM/Senior CPM/Lead CPM to deliver clinical studies from study protocol through study report and trial master file (TMF) archiving to ensure that timelines, quality and study objectives in accordance with the corporate objectives and *** Standard Operating Procedures (SOPs), International Council for Harmonization Good Clinical Practice (ICH GCP) and regulatory requirements are met. In addition, the ACPM supports the CPM/Senior CPM/Lead CPM by fostering the adoption of innovative practices at ***.
The ACPM collaborates closely with the CPM/Senior CPM/Lead CPM, who retains overall accountability for the study and determines which activities are delegated to the ACPM.
Key Responsibilities (may be delegated by the CPM/Senior CPM/Lead CPM to the ACPM)
Study Documentation Management
Maintain the trial master file (TMF) in an inspection-ready state to be complete, accurate, and legible through section reviews and oversight of cross-functional TMF responsibilities.
Participate in the review and finalization of clinical study-related documents and plans including, but not limited to, protocols, protocol amendments, informed consent form, clinical study reports (CSRs), regulatory submissions, IMP Handling Manual, TMF Plan, Study Management Plan and other study documents/plans as required.
Provide support for obtaining the Clinical Outcome Assessments (COA) and liaising with PCOR Lead, COM and other stakeholders under the supervision of the CPM/Senior CPM/Lead CPM.
Provide input into contracts, work orders and/or change orders and assist with review and management of invoice tracking/reconciliation.
Monitor clinical data collection to ensure data quality.
Project Communication
Manage stakeholder communications between internal teams and designated vendors.
Track study status and deliver updates and reports to stakeholders and senior management using *** and CRO metrics and systems.
Engage in efficient vendor and site coordination.
Participate in study-related meetings such as Study Team Meetings, Joint Clinical Study Team (JCST) meetings, Investigator Meetings, CRA workshops, and CRO training sessions.
Document team action items and decisions in accordance with the project communication plan.
Create and maintain the *** Study Team list, manage study SOP listings, and provide periodic updates.
Set up, maintain, and close study MS Teams channels and facilitate communication across these platforms, in collaboration with CROs as applicable.
Quality Management & Process Improvement
Support audit and inspection activities, ensuring readiness and timely resolution of findings in compliance with regulations (e.g., ICH GCP) and quality standards.
Assist with suspected serious breach assessments when applicable.
Contribute to process improvement initiatives, seeking efficiencies between *** and CRO systems (e.g., CTMS, TMF, Source Quality, SharePoint, Microsoft Teams), and share best practices with line managers, peers, and partner CROs.
Training Support
Develop and oversee study-specific training to ensure Study Team Members (STMs) adhere to protocol and study procedures.
Maintain the training matrix, including compliance tracking and development of training packages for Investigator Meetings, CSM trainings, and site initiation visits.
If delegated, oversee operational aspects of Investigator Meetings, collaborating with CROs, meeting planners, and vendors, and manage associated documentation and follow-up actions.
System Support
Set up studies in the *** Clinical Trial Management System (CTMS).
Conduct ongoing and final quality control checks in CTMS, liaising with CROs, CPMs, and CSOL (for iHome studies) to provide feedback and resolve issues.
Provide helpdesk support for clinical systems used by sites and sponsors.
Perform other study-related tasks assigned by the study team or CPM/Senior CPM/Lead CPM.
Education
Bachelor's degree
Competencies
An Associate Clinical Project Manager (ACPM) demonstrates an emerging-to-basic knowledge and application of technical and operational project management, interpersonal, and leadership competencies, which will include 1-2 years of CRA experience or similar and also the following:
General project management
Clinical project management
Operational clinical project management experience (phase 1 to phase 4 studies), including an understanding of the complexities of Global Clinical Development and Operations in
Early Phase Management Experience with Phase 1 or exploratory trials, often involving first-in-human studies and intensive safety monitoring.
Phase 2/3 Experience in pivotal trials that assess efficacy and safety at scale, often under regulatory scrutiny.
Late Phase and Post-Approval Study Management Involvement in realworld evidence generation, long-term safety follow-up, and market support studies. Includes NIS, PASS, and ISEG studies.
Technical ability (using *** systems and applications and proficiency in the Microsoft office suite)
Ability to interpret and use data and key performance indicators
Process and operational excellence
*** processes knowledge and process management
Languages: English: excellent written and oral.
Interpersonal
Self-Management & Personal Effectiveness
Organized and well-structured
Time management and planning
Self-awareness and self-regulation
Resilience
Sense of urgency with calm demeanor
Can-do attitude / proactivity / willing to learn and to develop
Relational Intelligence & Communication
Empathy
Listening
Conflict resolution
Clear and structured communication with appropriate escalation
Cultural awareness
Good presentation skills
Leadership
Driving Results & Accountability
Results and solution oriented
Ability to use circle of influence at all levels
Application of negotiation skills
SP Stakeholder Engagement
Customer focus and adaptability towards stakeholders
Effective networking
The ACPM represents *** professionally, aligning conduct with *** values, and possesses the knowledge and experience to perform tasks independently or under supervision, demonstrating desired behaviors within assigned projects and therapeutic areas.
(Competency level: Learn and Support)
#J-18808-Ljbffr