US - Associate Clinical Project Manager (ACPM)

US - Associate Clinical Project Manager (ACPM)#26-11886

Raleigh, NC

All On-site

Job Description

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 project's

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)

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.