Top 11 Study lead fsp team Jobs in Morrisville, Nc

Principal Clinical Trial Coordinator - FSP
Thermo Fisher Scientific —North Carolina
- Full-time
- Remote
- Office
- Bachelor's degree
- Team management
14d
Senior Epidemiologist, HIV Treatment, Retrospective Claims Study Expertise (FSP Sponsor Dedicated)
IQVIA —Durham, NC
- $109,200 - $273,000 a year
- Full-time
- Remote
- 7 years
- Master's degree
- Analysis skills
- Work from home
Clinical Team Lead, FSP - Oncology - US & Canada
Fortrea —Durham, NC
- $135,000 - $142,000 a year
- Weekends as needed
- Microsoft Excel
- English
- 3 years
RWE Clinical Project Manager (FSP)
IQVIA —Durham, NC
- $93,100 - $232,800 a year
- Full-time
- Remote
- Mid-level
- Bachelor's degree
- Continuous improvement
- Work from home
FSP Contract Negotiator
IQVIA —Durham, NC
- $49,200 - $157,100 a year
- Full-time
- Remote
- Presentation skills
- Bachelor's degree
- Mentoring
- Work from home
Principal Epidemiologist, Internal Medicine, Inflammation & Immunology (FSP Sponsor Dedicated)
IQVIA —Durham, NC
- $109,200 - $273,000 a year
- Full-time
- Remote
- Internal Medicine
- Master's degree
- Doctor of Philosophy
- Work from home
Director, Clinical Operations Program Leadership (COPL)
Biogen —Research Triangle Park, NC
- $209,000 - $288,000 a year
- Full-time
- Hybrid work
- 11+ years
- Bachelor's degree
- Doctor of Philosophy
- Paid parental leave
- Employee stock purchase plan
Senior Epidemiological Programmer RWE - Oncology
IQVIA —Durham, NC
- $88,300 - $220,900 a year
- Full-time
- Remote
- 3 years
- Master's degree
- SQL
- Work from home
Associate Principal Statistical Programmer, PKPD
IQVIA —Durham, NC
- $88,300 - $220,900 a year
- Full-time
- Remote
- 8 years
- Analysis skills
- Senior level
- Work from home
1d
Site Budgeting and Contracting Specialist - FSP
Fortrea —Durham, NC
- Full-time
- Mid-level
- Office
- Bachelor's degree
- Employee stock purchase plan
- Disability insurance

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Based on your search for study lead fsp team

Principal Clinical Trial Coordinator - FSP
Thermo Fisher Scientific —North Carolina
Support study close-out activities including final TMF Review and TMF certification form (DEV-FORM-1939) completion.
14d
Clinical Team Lead, FSP - Oncology - US & Canada
Fortrea —Durham, NC
University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from…
$135,000 - $142,000 a year

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Principal Clinical Trial Coordinator - FSP

Thermo Fisher Scientific -
North Carolina

Apply Now

Job Details

Full-time
14 days ago

Qualifications

Project team coordination
Meeting minutes
Data quality checks
Contract documentation review
Contract review
Office activity coordination
Document control experience within pharmaceutical industry
Non-disclosure agreements (NDAs)
Vendor coordination
Filing
Team scheduling
Technical support
Data summary reports
Research project coordination
Quality assurance audits
Bachelor's degree
Quality control documentation
Team management
Team training
Schedule creation
Clinical trial standard operating procedures
Regulatory submissions
Clinical research inspection readiness
Technical writing quality assurance
Project contract management
Clinical trial site selection
Senior level
Ethical review application preparation
Achieving project delivery timelines
Escalation handling

Full Job Description

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.

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Refine Your Search

study lead fsp team jobs in morrisville, nc

Principal Clinical Trial Coordinator - FSP

Senior Epidemiologist, HIV Treatment, Retrospective Claims Study Expertise (FSP Sponsor Dedicated)

Clinical Team Lead, FSP - Oncology - US & Canada

RWE Clinical Project Manager (FSP)

FSP Contract Negotiator

Principal Epidemiologist, Internal Medicine, Inflammation & Immunology (FSP Sponsor Dedicated)

Director, Clinical Operations Program Leadership (COPL)

Senior Epidemiological Programmer RWE - Oncology

Associate Principal Statistical Programmer, PKPD

Site Budgeting and Contracting Specialist - FSP

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