Associate Clinical Project Manager (ACPM)

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 support 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.
The following key responsibilities may be delegated by the CPM/Senior CPM/Lead CPM to the
ACPM:
Study Documentation Management:
Maintaining 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 projects
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 - Bachelors

Competencys
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:
Technical and operational project management:
- General project management
- Clinical project management:
o Operational clinical project management experience (phase 1 to phase 4
studies), including an understanding of the complexities of Global Clinical
Development and Operations in:
o Early Phase Management Experience with Phase 1 or exploratory trials,
often involving first-in-human studies and intensive safety monitoring.
o Phase 2/3 Experience in pivotal trials that assess efficacy and safety at
scale, often under regulatory scrutiny.
o 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:
o *** processes knowledge and process management
o Languages: English: excellent written and oral.
Interpersonal:
- Self-Management & Personal Effectiveness:
o Organized and well-structured
o Time management and planning
o Self-awareness and self-regulation
o Resilience
o Sense of urgency with calm demeanor
o Can-do attitude / proactivity / willing to learn and to develop
- Relational Intelligence & Communication:
o Empathy
o Listening
o Conflict resolution
o Clear and structured communication with appropriate escalation
o Cultural awareness
o Good presentation skills
Leadership:
- Driving Results & Accountability:
o Results and solution oriented
o Ability to use circle of influence at all levels
o Application of negotiation skills
- SP Stakeholder Engagement:
o Customer focus and adaptability towards stakeholders
o 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)