Full-Time
Associate Director
Clinical Operations, Clinical Research
Posted on 1/21/2025
Celerion
1,001-5,000 employees
Clinical research organization for drug development
No salary listed
Senior
Tempe, AZ, USA
- Bachelor’s degree in Business, Science or health-related field or BSN
- Proven organizational skills
- Ability to manage multiple priorities
- Excellent oral and written communication skills
- Knowledge of medical terminology preferred
- Ability to work without close supervision
- Ability to work hours required for study conduct
- Level based on years of experience in medical, pharmaceutical or related field of operations
- Ability to work flexible schedule
- Responsible for staff management in accordance with the organization's policies and applicable laws.
- Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees.
- Overall management of clinical studies
- On-time performance with defect-free execution
- Work with Clinical Support Coordinator, study design and recruiting to schedule studies
- Set up study initiation meetings to plan execution of study
- Conduct study review meetings for pre-study, in-process and post-study review
- Problem solve as needed during study conduct
- Meet with clients as needed throughout study
- Organize study logistics and personnel
- Be present at critical events and dosings of study
- Maintain profitability of team through budgeting and expense control on a total and individual study basis
- Monitor overtime
- Coordinate with purchasing to ensure expense control
- Interpret and implement study specification sheet
- Manage/supervise associates during study conduct
- Assign duties to clinic staff
- Assess and take action as special situations occur in study conduct
- Ensure timely and accurate data is collected
- Ensure compliance with client protocol, Standard Operating Procedures and federal regulations
- Respond to Quality Assurance audits in timely manner
- Implement monthly meetings to review management reports
- Build relationships with community
- Identify physician resources
- Enhance marketing and recruiting
- Provide client services to consumer product and clients
- Assume responsibility for facility management
- Develop opportunities for computerization of alternative methods of data entry; bar-coding, utilizing specs/Time & Event Schedule
- Identify additional training requirements (outpatient) for Clinical Research Tech training manuals
- Knowledge of medical terminology preferred
Celerion specializes in early phase drug development as a clinical research organization (CRO). The company provides a range of services to pharmaceutical and biotechnology companies, including clinical trial design, feasibility studies, project management, and regulatory affairs. Celerion uses advanced bioanalytical techniques, particularly High Resolution Mass Spectrometry (HR MS), for metabolite profiling and identification, which enhances their research capabilities. This focus on bioanalytical sciences and their extensive experience allows Celerion to assist clients in making informed decisions during the early stages of drug development. Unlike many competitors, Celerion emphasizes speed and quality in research, aiming to help clients bring their treatments to market more quickly, ultimately benefiting patients globally.
Company Size
1,001-5,000
Company Stage
Acquired
Total Funding
N/A
Headquarters
Lincoln, Nebraska
Founded
2010
Simplify's Take
What believers are saying
- Rising demand for early-phase trials due to personalized medicine boosts Celerion's market.
- Advancements in AI enhance Celerion's bioanalytical data analysis and metabolite profiling.
- Expansion into cell and gene therapy markets aligns with Celerion's service offerings.
What critics are saying
- Emerging CROs offering similar services at lower costs threaten Celerion's market share.
- Regulatory changes in the EU and China could increase compliance costs for Celerion.
- Talent shortages in the pharmaceutical sector may hinder Celerion's ability to retain staff.
What makes Celerion unique
- Celerion specializes in early-phase drug development with over 40 years of experience.
- The company excels in metabolite profiling using High Resolution Mass Spectrometry (HR MS).
- Celerion's global operations offer comprehensive services from trial design to regulatory affairs.
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Benefits
Flexible Work Hours
Growth & Insights and Company News
6 month growth
↑ 4%1 year growth
↑ 4%2 year growth
↑ 4%Celerion was recognized as a CRO Leader in the quality, capabilities and reliability categories across two groups of respondents (small pharma and combined big and small pharma).
LINCOLN, Neb.--(BUSINESS WIRE)--Celerion, a leading clinical research organization, specializing in early clinical research and bioanalytical services, today announced the appointment of Jo Goodman as vice president of bioanalytical services in its Lincoln, Nebraska, laboratory. In her new role, Goodman will oversee the strategic direction and operational performance of the Lincoln bioanalytical laboratory, leveraging her extensive experience in pharmaceutical research and development to drive innovation and design and execute customized bioanalysis for clients’ needs. She will be responsible for delivering on Celerion’s bioanalytical promise of industry-leading science, stringent compliance, and speed of delivery. With over 29 years of experience in the pharmaceutical industry, Goodman brings a wealth of knowledge in regulated GxP and discovery bioanalysis for both in-house and outsourced activities. Prior to joining Celerion, she held positions of increasing responsibility at AstraZeneca, MedImmune, and GlaxoSmithKline. Additionally, Goodman is a recognized thought leader, having recently served as a member of the Expert Working Group (EWG) for ICH M10 Bioanalytical Guidance Development and is active in numerous non-profit industry consortia such as EBF, AAPS, and DMDG
Celerion announced the appointment of Jo Goodman as vice president of bioanalytical services in its Lincoln, Nebraska, laboratory.Post this
LINCOLN, Neb--(BUSINESS WIRE)--Celerion, a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) certification for its state-of-the-art bioanalytical laboratory located in Lincoln, Nebraska. This significant milestone marks a pivotal step in Celerion’s commitment to advancing healthcare by integrating high-complexity testing and diagnostic services into its comprehensive suite of bioanalytical solutions. Celerion’s clinical laboratories, including their Lincoln site, have been CLIA-certified and CAP-accredited for over 25 years, which helped facilitate the CLIA certification of the laboratory. The CLIA certification is a testament to Celerion’s adherence to the highest standards of laboratory quality and competence. It enables Celerion to conduct non-waived testing on human specimens, a critical component in the health assessment, diagnosis, prevention, and treatment of diseases. This certification is particularly crucial as it allows Celerion to perform these vital tests prior to the full accreditation inspection by a CMS-approved agency, ensuring continuous advancement in patient care and clinical research
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