US - Associate Clinical Project Manager (ACPM)

Job Description:
Job Title: Associate Clinical Project Manager
Job Duration: 12 months contract
Location: Raleigh NC 27617
Job Description
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 organization's 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 organization.
*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 organization 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 organization 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 organization and CRO systems (e.g., CTMS, TMF, Source Quality, SharePoint, MS 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 organization 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

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:
Technical and operational project management:
*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.
• o Late Phase and Post-Approval Study Management- Involvement in real world evidence generation, long-term safety follow-up, and market
• support studies. Includes NIS, PASS, and ISEG studies.
• Technical ability (using organization systems and applications and proficiency in the MS 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 organization professionally, aligning conduct with organization values, and possesses the knowledge and experience to perform tasks independently or under supervision, demonstrating desired behaviors within assigned projects and therapeutic areas.

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals.To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.