Top 6 Clinical trial administrator Jobs in Denver, Co

Drug Supply/Clinical Trial Supply Manager
CPC Clinical Research —Aurora, CO
- $70,000 - $90,000 a year
- Full-time
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Paid holidays
- Disability insurance
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Associate Clinical Trial Manager - PhD - Metabolic - Denver, CO
Medpace, Inc. —Denver, CO
- $70,000 - $90,000 a year
- Full-time
- Word processing
- English
- Mid-level
- Travel reimbursement
- AD&D insurance
Office of Clinical Trials (OCT) Coordinator
University of Colorado —Aurora, CO
- $56,995 - $72,498 a year
- Overtime
- Hybrid work
- Background check
- Microsoft Excel
- Microsoft Outlook
- Disability insurance
- Health insurance
Open Rank Clinical Trials Coordinator (Intermediate – Senior)
University of Colorado —Aurora, CO
- $54,302 - $74,665 a year
- Overtime
- Background check
- Anatomy knowledge
- Vital signs
- Disability insurance
- Health insurance
Senior Financial Analyst, Grants Administration (Clinical Trials Services)
Denver Health —Denver, CO
- $76,100 - $114,200 a year
- Full-time
- Customer service
- Pass drug screening
- Mid-level
- Paid parental leave
- Paid holidays
Physician - Clinical Trials - MD/DO
Headlands Research —Denver, CO
- Part-time
- Medicine
- Management
- BC/BE
- Flexible schedule
- Life insurance

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Drug Supply/Clinical Trial Supply Manager

CPC Clinical Research -
Aurora, CO

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Job Details

Full-time
$70,000 - $90,000 a year

Benefits

Paid holidays
Disability insurance
Health insurance
Dental insurance
Vision insurance
401(k) matching
Paid sick time

Qualifications

Microsoft Word
Microsoft Excel
Microsoft Outlook
Presentation software
Drug regulation
GMP
ICH guidelines
Pharmaceutical company experience
Logistics compliance
Regulatory compliance analysis
Demand forecasting for production planning

Full Job Description

We are looking for a Drug Supply/Clinical Trial Supply Manager to join our team!

Responsible for timely and accurate provision of investigational product(s) (IP) for CPC Clinical Research clinical trials. This includes managing outsourcing to external vendors [Contract Manufacturing Organizations (CMOs)] to ensure labeling, packaging and shipping of IP in compliance with applicable regulations.

Clinical Supply Management (General)

Establish and document supply chain for each project according to required scope
Manage supply planning/forecasting to ensure alignment with study activity and timelines
Assist Legal with obtaining procurement and/or supply agreements for any required commercially sourced products
Monitor inventory levels at sites and depots through the life of a trial taking preventative actions to avoid supply issues
Manage, reconcile, maintain and report an accurate account of IP inventory on-hand, consumption, movements, lot and expiry tracking
Collaborate with study team and vendors to assure proper distribution of IP to study sites
Develop excellent working relationships with QA / RA for timely review and approval of batch records for packaging and labeling of IP

Coordinate with manufacturer counterparts and their vendors to efficiently manage drug supply
Support organizational innovation in pragmatic trial design and conduct
Support development of study specific manuals and work with QA to develop supply related training/instructional materials (i.e., Pharmacy Manual, Investigator Meeting and Site Initiation Visit slides, Dosing Cards, Diaries, etc.)

Participate in relevant team meetings providing clinical supply status reports

Follow up on reported Temperature Excursions and/or Product Complaints from sites/depots

Ensure expiry extensions are provided to depot/sites as needed to support continued use
Manage return and destruction of IP under the direction of RA, with proper documentation of all steps
Ensure appropriate documentation of IP supply activities are filed in the electronic Trial Master File

Packaging and Labeling

Facilitate the design, review, and approval of IP label text and proofs to meet specific country language(s), translations and regulatory requirements
Facilitate the development, review, and approval of supply packaging configurations and specifications
Plan and coordinate Vendor activities for scheduling and production of labels and primary/secondary packaging of IP
Liaise with appropriate parties to ensure adequate IP supply releases are obtained per applicable regulations (Qualified Person Release, Certificates of Analysis/Batch Release Certificate, Compliance, etc.)

Coordinate expiry date extensions and re-labeling operations, when applicable
Manage maintenance of appropriate quantity of retain samples

Qualifications:

Bachelor’s Degree or higher in health or life sciences, preferred
Minimum of 4 years’ experience in the pharmaceutical/biotechnology industry performing global clinical trial supply logistics/management, including supply chain and labeling
Experience interpreting clinical trial protocols and developing well-planned, accurately forecasted clinical supply forecasts
Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives
Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook, etc.), Electronic Data Capture systems
Demonstrated leadership capabilities, effective organizational skills, and excellent verbal and written communication
Ability to work in a fast-paced, complex environment amongst internal and external partners

Note: Viable applicants will be required to pass a background and education verification check.

Targeted Compensation: $70,000 - $90,000 annually

About CPC:

CPC is an academically led clinical research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.

CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.

CPC offers:

Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
10 paid holidays
15 - 25 vacation days based on years of service
Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
Flexible and remote work schedules

An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, sex, gender identity, veteran status, marital status, sexual orientation, age forty and over, disability, genetic information or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at [email protected].

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Refine Your Search

clinical trial administrator jobs in denver, co

Drug Supply/Clinical Trial Supply Manager

Associate Clinical Trial Manager - PhD - Metabolic - Denver, CO

Office of Clinical Trials (OCT) Coordinator

Open Rank Clinical Trials Coordinator (Intermediate – Senior)

Senior Financial Analyst, Grants Administration (Clinical Trials Services)

Physician - Clinical Trials - MD/DO

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