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Job Details

Skills

Innovation
Pharmaceutics
Clinical Trials
Administrative Support
Project Coordination
EDP
TMF
Security Clearance
Project Finance
Regulatory Compliance
Effective Communication
Quality Assurance
Auditing
Technical Support
Management
Document Processing
Reporting
SAP BASIS
Scheduling
Veeva
Database
Documentation
Distribution
Insurance
Translation
Quality Control
eXist
INV
Collaboration
Training

Summary

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Join Us as a Principal Clinical Trial Coordinator FSP- Make an Impact at the Forefront of Innovation! We have successfully supported the top 50 pharmaceutical companies and more than 750 biotech's, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

Summary of Essential Functions:

Attends kick-off meetings and supports training to team members, investigators, or clients as needed.

Serves as study eTMF lead, handling client integration and (e)TMF activities.

Provides technical and administrative support for project coordination to meet study-level milestone targets.

Assists with preparation and review of EDP/RCR packages.

Supports development of country or site-specific documents.

Support study close-out activities including final TMF Review and TMF certification form (DEV-FORM-1939) completion.

Support with preparations for Investigator Meetings

Maintaining and coordinating the logistical aspects of clinical projects and provide overall support to functional leads to ensure the successful completion of project deliverables.

Initiates the preparation of all project/program plans required by client contracts by reviewing contract and communicating with functional area leads.

Coordinates project/program/protocol specific and therapeutic area training needs. Tracks and follows up on all training, non-disclosure agreements, and security clearance requests.

Performs basic project financial management tasks as assigned.

Acts as task order/work assignment lead on small scopes of work for contracts/projects of low complexity.

Escalates compliance to established project-specific parameters and client expectations.

As Project Specialists ensures the contracted services and expectations of assigned projects are carried out by the project teams in accordance with executed contracts and the customers' requirements.

Maintaining timely and effective communication among team members, site staff and providing support for quality assurance activities, including preparation for audits and internal review, preparing documentation and follow through to resolution.

Maintenance and tracking of SOPs, client directives, and regulatory guidelines at the project level.

Contributes to discussions with teammates to support collaboration and best practices.

Expands therapeutic knowledge and expertise.

In addition to tasks listed above essential functions will include tasks below with increased skill level and years of experience above Principal CTC.

Develops site list and ensures contact details are maintained in Client/PPD systems including Veeva.

Provides admin and technical support to study management and program teams, including:
- Supports meeting scheduling, minute taking, document creation and transmission.
- May maintain vendor trackers.
- Works with sites to obtain relevant documents.
- Completes site interest plan and documents site communications.
- Works directly with sites to obtain site qualification, selection and start-up documents.
- Works with CSO to develop the site list and ensures contact details are maintained in Client/PPD systems including Veeva.

Performs document processing and follow-up tasks, including:
- Initial quality checks of eTMF documents, file reviews, and documents findings.
- Request eTraining report reviews to begin on a quarterly basis
- Performs file reviews and documents findings in appropriate system, including tracking local regulatory documents.
- Supports maintenance of study-specific documentation and global systems/tools.
- May conduct quarterly eTMF completeness checks.

Coordinates and completes assigned activities ensuring proactive scheduling and fulfillment, aligned with project team needs, including:
- Provides system access (e.g., Veeva & eTMF) and inputting site and study information into current databases and generating reports.
- Analyzes and reconcile study metrics and findings reports, clarifying and resolving issues related to site documentation.
- Assists with coordination, compilation, and distribution of Investigator Site File (ISF) and supplies to sites.
- May maintain vendor trackers.
- Ensures efficient site contact and follow-up plan, escalating concerns as needed.

Assists with Study Start-up and ongoing submission activities as needed
- Transmits documents to centralized IRB/IEC (on-going).
- Request insurance in each country
- Coordinates with key QSDO functions to align site start-up activities.
- May support study-specific translation of materials and QC.
- May be requested to help with checking if CDAs exist/are expired & obtaining a new Inv/Institution CDA.
- May work with the CTT Representative, to provide relevant study information

Other essential tasks and principal duties:
- Supports survey data review and collaboration with teammates.
- May liaise and contributes to feasibility processes.
- Compliant with general and study specific training, ensuring knowledge of relevant SOPs and regulatory guidance.
- Contributes to the development of best practices.

Education and Experience:
Bachelor\'s degree preferred.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: recfeed
Position Id: R-01362821
Posted 17 hours ago

Head of Clinical Data Management

Remote or New Jersey

•

Today

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great P

Full-time

USD 255,000.00 - 347,500.00 per year

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Principal Clinical Trial Coordinator - FSP

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Principal Clinical Trial Coordinator - FSP

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