Danielle Allen
Insmed Inc.
Mount Juliet
1
Certification
17
years of professional experience
Experienced clinical research professional with 13 years in managing complex clinical trials and ensuring regulatory compliance. Drives project success through effective team collaboration. Focused on advancing medical knowledge and improving patient outcomes while excelling in fast-paced environments.
Work History
CLINICAL TRIAL MANAGER
1 Year 5 Months- Manages end-to-end clinical trial operations, including site activation, enrollment, and closeout activities
- Manages third-party vendors and CROs to contracted deliverables, maintaining quality, cost, and timeline standards; proactively identifies scope changes and coordinates change orders
- Oversees site-level monitoring activities to ensure adherence to performance and quality standards
- Develops and maintains project plans and trial documentation to ensure alignment with study objectives
- Collaborates cross-functionally with clinical scientists, development leads, and study teams to review data listings and support data integrity
- Contributes to the development and review of departmental SOPs and process improvement initiatives
MANAGER, CLINICAL VENDOR ALLIANCE MANAGEMENT
1 Year 4 Months- Contributed to governance and audit processes for specialty vendor across Insmed portfolio, ensuring compliance and quality.
- Participated in the Vendor Oversight Committee.
- Engaged in regulatory inspections.
SENIOR CLINICAL VENDOR MANAGEMENT ASSOCIATE
1 Year 9 Months- Managed vendor relationships, ensuring compliance with procurement standards and contract requirements.
- Managed vendor onboarding, contract documentation, and compliance requirements across cross-functional teams.
- Coordinated procurement activities, purchase orders, and invoice approvals to support operational continuity.
CONTRACT CLINICAL VENDOR MANAGEMENT ASSOCIATE
4 Months- Participated in selection, management, and oversight of vendors for services such as central clinical labs, specialty testing labs, and diagnostic testing vendors.
• Assisted the team with the management of clinical supplies and equipment distribution and receipt to all clinical sites, including coordination with internal and external stakeholders as necessary.
• Evaluated metrics and Key Performance Indicators to ensure oversight of clinical trial progress.
• Assisted with financial management of vendors, including invoice reconciliation, budgeting, monthly/quarterly accruals, and variance reporting for vendor contracts as needed.
• Assisted with development of processes and tools to support outsourcing oversight and study processes, as needed.
• Reviewed study documents related to specialty vendors (e.g., study plans, guidelines, operations manuals, training materials, trackers).
• Worked directly with investigational sites to answer questions, train, and serve as liaison with vendor(s) to ensure issues are escalated and addressed thoroughly and quickly. - Managed vendor onboarding, ensuring compliance with procurement policies and quality requirements.
- Coordinated supplier communications to resolve order discrepancies and delivery issues.
- Negotiated contract terms, balancing cost efficiency, quality expectations, and business continuity.
CLINICAL RESEARCH ASSOCIATE
10 Months- Worked with relevant departments (Regulatory Affairs, Product Support, Program Management, Marketing) to aid in design and preparation of clinical and analytical performance study plans, protocols, reports, and associated study data collection forms.
- Completed set-up, initiation, execution, and close-out of device clinical trials, ensuring adherence to timelines and regulatory standards.
- Conducted monitoring visits to evaluate clinical trial sites and ensure regulatory compliance.
- Leads the development, organization, implementation, and completion of clinical studies according to FDA standards and Good Clinical Practice (GCP).
- Provided technical training and monitoring; coordinated daily activities of trial sites; assisted sites in planning and implementing subject recruitment activities.
- Educated and assists sites to ensure timely subject screening and enrollment.
- Conducted assessments of complications and serious adverse events.
- Made IRB submissions, addenda and renewals.
- Provided technical support and training to clinical investigators and their staff regarding trial information, the protocol, clinical, and regulatory requirements.
- Negotiated site-specific study budgets, initiated and oversaw contract finalization. Completed the tracking of budgets for studies.
- Represented Global Clinical Affairs on multifunctional teams tasked with preparing responses to regulatory agencies.
- Collaborated and negotiated with potential CROs regarding RFPs and performed bid comparisons.
CLINICAL RESEARCH ASSOCIATE I
1 Year 10 Months- Responsible for hands-on site management and monitoring of an observational clinical study (3 US sites).
- Performed onsite monitoring visits, including site qualification, site initiation, interim monitoring, and study site closeout visits.
- Motivated sites to meet study enrollment and follow-up visit timelines, ensuring compliance with clinical milestones.
- Acted in a patient logistics role serving as liaison/point of escalation for sites, vendors, and CRAs regarding complex screening and enrollment process, including direct-to-patient IP shipments and home nurse visits.
- Acted as liaison and point of escalation for sites, vendors, and CRAs regarding complex screening and enrollment processes, including direct-to-patient IP shipments and home nurse visits.
- Identified, analyzed, and reported compliance issues; and develops actions for remediation.
- Contributes to the revision of clinical documents such as site Informed Consent Forms (ICFs), study logs and forms, source document worksheets, and other documentation required for the conduct of a clinical trial.
CLINICAL TRIAL ASSOCIATE II
1 Year- In addition to the Clinical Trial Associate (CTA) responsibilities listed below:
- Provided mentorship and oversight to CTAs by offering guidance and training involving study specific tasks and department processes. Examples of trainings include:
- CTA role in the Precision study start-up process
- Trial Interactive eTMF initial setup, maintenance, and file review process (all roles, including administrator)
- ICF review (how to complete the ICF checklist, perform document comparison to study ICF template, what to escalate for additional review).
- Performed investigator debarment checks to ensure compliance with regulatory requirements.
- Documented meeting outcomes to ensure clear communication among team members. (discuss how to summarize, what details to note, ongoing review of junior CTA minutes with feedback)
- Communicated with sites to provide and obtain necessary regulatory documents, site status trackers, and study supplies.
- Sourced clinical study supplies from external vendors to ensure timely availability for study needs.
- Assisted in processing financial items by providing project receipts and tracking information for Finance Department, facilitating accurate budget management.
- Prepared and maintained study-specific trackers, including site contact list, FAQ log, and master screening and enrollment logs, to enhance organization and accessibility of key study data.
- Completed co-monitoring visits to aid in source document and regulatory document reviews.
- Reviewed ICFs and advertisements to ensure all required elements have been included. Provides sites with permission to submit to IRBs.
CLINICAL TRIAL ASSOCIATE
2 Years- Provided support to the Clinical Operations and Project Management departments through the performance of project-specific tasks, contributing to the overall management of clinical trials.
- Supported clinical study teams in managing all aspects of study from start-up to close-out across multiple studies, ensuring compliance and timely execution.
- Served as the Subject Matter Expert for all TMF activities, including sponsor TMF audits; resolved and responded to any findings.
- Managed shipments of clinical materials (tracked, shipped high-value medical equipment/supplies and other print materials/tools, managed re-supply and returns).
- Drafted minutes and managed action item tracking for meetings
- Conducted feasibility and site identification by summarizing completed feasibility questionnaires.
- Prepared, reviewed, and submitted essential documents to central IRBs for study and site level submissions, facilitating regulatory compliance and study progress.
- Assisted with set-up and routine maintenance of the eTMF system, including folder creation, updates to auto naming rules and required documents, inputting site information, document QC, and running reports.
- Trained clients and study team members on eTMF.
- Assisted in planning, organizing and executing project-specific meetings including but not limited to client meetings, CRA trainings, and Investigator Meetings.
- Maintained study related dashboards.
- Created study binders for clinical sites, including ISF and SRM.
- Prepared study specific correspondence, spreadsheets, and presentations utilizing Microsoft Office Suite (e.g. meeting minutes, newsletters, email blasts, screening and enrollment trackers).
CLINICAL RESEARCH ASSISTANT/INTERN
2 Years 4 Months- Coordinated logistics for clinical study start-up activities, generate, distribute and obtain required study documents.
- Managed the set-up and ongoing organization of the trial master file to ensure complete, accurate and current files of study records.
- Prepared and implemented Investigator Meetings.
- Tracked and organized weekly updates of subject enrollment logs for project visibility of subject enrollment logs.
- Performed clerical tasks and administrative duties to support the project team's operations.
CRYPTOLOGIC TECHNICIAN/ EMERGENCY MANAGEMENT ASSISTANT
3 Years 8 Months- Provided front desk support for Emergency Management department, facilitating communication and operations.
- Maintained vigilance to identify potential emergencies. and escalate emergencies/issues accordingly.
- Developed training presentations and tracked department training to enhance team preparedness.
- Create and edit SOPs and spreadsheets.
- Perform filing and data entry duties.
Education
Bachelor of Science - Biology
AS - Industrial Management Technology
Skills
Clinical trial oversight
Site monitoring
Site selection
Patient recruitment
Adverse event reporting
Audit preparation
Document review
Project management
Training and mentoring
Training coordination
Attention to detail
Reliability
Certification
CRA & CRC: Beginner Program – 2018, Clinical Project Management Fundamentals – 2022, Certified Clinical Research Associate (CCRA) – 2020 - Present
Timeline
CLINICAL TRIAL MANAGER
Insmed Inc.
05.2025 - CurrentRead More
MANAGER, CLINICAL VENDOR ALLIANCE MANAGEMENT
Insmed Inc.
01.2024 - 05.2025Read More
SENIOR CLINICAL VENDOR MANAGEMENT ASSOCIATE
Insmed Inc.
04.2022 - 01.2024Read More
CONTRACT CLINICAL VENDOR MANAGEMENT ASSOCIATE
Insmed Inc.
12.2021 - 04.2022Read More
CLINICAL RESEARCH ASSOCIATE
Leica Biosystems
01.2021 - 11.2021Read More
CLINICAL RESEARCH ASSOCIATE I
Precision for Medicine
02.2019 - 12.2020Read More
CLINICAL TRIAL ASSOCIATE II
Precision for Medicine
02.2018 - 02.2019Read More
CLINICAL TRIAL ASSOCIATE
Agility Clinical, Inc.
02.2016 - 02.2018Read More
CLINICAL RESEARCH ASSISTANT/INTERN
Collaborative Clinical Research Consulting Inc.
10.2013 - 02.2016Read More
CRYPTOLOGIC TECHNICIAN/ EMERGENCY MANAGEMENT ASSISTANT
United States Navy
06.2009 - 02.2013Read More
National University
Bachelor of Science from Biology
Read More
Florida State College
AS from Industrial Management Technology
Read More
Therapeutic Experience
- Phase | Indication | Countries | No. Sites | Role
- II | Cataracts | United States | 12 | CTA
- III | NLRC4 Mutation and XIAP Deficiency | United States, Canada, Germany | 10 | CTA, Co-Monitor
- I/IIA | Age-Related Macular Degeneration (AMD) | United States | 5 | CTA
- II | Eosinophilic Esophagitis | United States, Canada, Switzerland | 40 | CTA
- II | Sexual Dysfunction | United States | 15 | CTA
- I | Pulmonary Arterial Hypertension (PAH) | United States | 10 | CTA, Co-Monitor
- Observational | Preeclampsia | United States | 7 | CTA
- III | RBC Transfusion | United States | 7 | CTA
- III | Rett Syndrome | United States | 18 | CTA, CRA - Patient Logistics Role
- Observational | Pancreatic Cancer | United States, Canada, United Kingdom, Spain, Sweden | 25 | CRA (Monitor for 3 US sites)
- IV | Breast Cancer | United States | 4 | Project Lead, CRA (Monitor for 3 sites)
- III | Bronchiectasis | Global (North America, Latin America, Europe, Japan, and the Rest of the World) | Over 400 | Vendor Management
- II | Pulmonary Hypertension Associated with Interstitial Lung Disease | Global (North America, Latin America, Europe, Japan, and the Rest of the World) | 65 | Vendor Management
- IIb | Pulmonary Arterial Hypertension (PAH) | Global (North America, Latin America, Europe, Japan, and the Rest of the World) | 91 | Vendor Management
- IIb | Chronic Rhinosinusitis Without Nasal Polyps | Global (North America, Latin America, Europe, Japan, and the Rest of the World) | 102 | Vendor Management
- I | Duchenne Muscular Dystrophy | United States | 12 | Vendor Management
- IIb | Hidradenitis Suppurativa | Global (North America, Europe, Australia) | 72 | Clinical Trial Manager
- IIb/3 | Hidradenitis Suppurativa | Global (North America, Europe, Australia) |
- OLE currently in start-up | Clinical Trial Manager