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Clinical Development Biotech Jobs in Iowa (NOW HIRING)

Supporting the development of console and embedded software systems * Troubleshooting issues and ... As part of the Danaher family, Beckman Coulter Diagnostics is a global leader in clinical ...

Supporting the development of console and embedded software systems * Troubleshooting issues and ... As part of the Danaher family, Beckman Coulter Diagnostics is a global leader in clinical ...

Supporting the development of console and embedded software systems * Troubleshooting issues and ... As part of the Danaher family, Beckman Coulter Diagnostics is a global leader in clinical ...

Supporting the development of console and embedded software systems * Troubleshooting issues and ... As part of the Danaher family, Beckman Coulter Diagnostics is a global leader in clinical ...

Supporting the development of console and embedded software systems * Troubleshooting issues and ... As part of the Danaher family, Beckman Coulter Diagnostics is a global leader in clinical ...

Supporting the development of console and embedded software systems * Troubleshooting issues and ... As part of the Danaher family, Beckman Coulter Diagnostics is a global leader in clinical ...

Supporting the development of console and embedded software systems * Troubleshooting issues and ... As part of the Danaher family, Beckman Coulter Diagnostics is a global leader in clinical ...

Supporting the development of console and embedded software systems * Troubleshooting issues and ... As part of the Danaher family, Beckman Coulter Diagnostics is a global leader in clinical ...

Supporting the development of console and embedded software systems * Troubleshooting issues and ... As part of the Danaher family, Beckman Coulter Diagnostics is a global leader in clinical ...

Supporting the development of console and embedded software systems * Troubleshooting issues and ... As part of the Danaher family, Beckman Coulter Diagnostics is a global leader in clinical ...

... development activities specifically for therapeutic products from pre-clinical and Ph I clinical ... Our vision is to be the premier partner for biotech, government, and research institutions. We are ...

Supporting the development of console and embedded software systems * Troubleshooting issues and ... As part of the Danaher family, Beckman Coulter Diagnostics is a global leader in clinical ...

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Clinical Development Biotech information

What is clinical development in biotech?

Clinical development in biotech refers to the process of testing new drugs or therapies in human participants to determine their safety and effectiveness. This phase follows preclinical research and involves multiple stages of clinical trials, from Phase I (safety) to Phase III (efficacy and monitoring of side effects). Clinical development professionals coordinate the design, implementation, and analysis of these studies, ensuring compliance with regulatory standards. Their work is crucial in bringing innovative treatments from the laboratory to patients. Success in this field requires knowledge of medical science, regulatory guidelines, and project management.

What are the typical challenges faced by professionals working in clinical development within the biotech industry?

Professionals in clinical development for biotech companies often encounter challenges related to navigating complex regulatory requirements, managing tight timelines, and ensuring robust data quality across clinical trials. Additionally, frequent cross-functional collaboration is needed, as teams work closely with regulatory affairs, medical affairs, and data management to drive studies forward. Adapting to evolving scientific advancements and shifting project priorities are also common, so flexibility and strong communication skills are essential for success in this fast-paced environment.

What is the difference between Clinical Development Biotech vs Clinical Research Associate?

AspectClinical Development BiotechClinical Research Associate
Required CredentialsBachelor's or higher in life sciences, relevant certificationsBachelor's in life sciences, often with CRA certification
Work EnvironmentPharmaceutical/biotech companies, labs, clinical trial teamsMonitoring sites, clinical trial sites, sponsor offices
Employer & Industry UsageBiotech firms, pharmaceutical companies, CROsPharmaceutical companies, CROs, research organizations
Common Search & ComparisonYesYes

The Clinical Development Biotech role focuses on planning and managing clinical trials within biotech companies, often involving protocol development and regulatory submissions. In contrast, a Clinical Research Associate primarily monitors clinical trial sites to ensure compliance and data integrity. While both roles require similar educational backgrounds and certifications, their daily responsibilities and work environments differ, with the former being more involved in trial design and the latter in trial oversight.

What are the key skills and qualifications needed to thrive as a Clinical Development professional in biotech, and why are they important?

To thrive in Clinical Development within biotech, you need a strong background in life sciences, clinical trials management, and regulatory compliance, often supported by an advanced degree (e.g., PhD, PharmD, or MD). Proficiency with clinical trial management systems (CTMS), data analysis tools, and familiarity with ICH-GCP guidelines and FDA regulations are typically required. Strong project management, communication, and problem-solving skills help navigate complex studies and multidisciplinary teams. These competencies are essential to ensure safe, efficient, and compliant development of new therapies from concept to market.
What are popular job titles related to Clinical Development Biotech jobs in Iowa? For Clinical Development Biotech jobs in Iowa, the most frequently searched job titles are:
What cities in Iowa are hiring for Clinical Development Biotech jobs? Cities in Iowa with the most Clinical Development Biotech job openings:

Clinical Research Site Manager

Eximia Research

West Des Moines, IA โ€ข On-site

Other

Posted 18 days ago


Job description

Company Description



Eximia Research is a fully Integrated research sites network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). Our premier, multidisciplinary wholly owned research sites located across country and known for excellent trial execution, rapid subject recruitment/enrollment and delivery of a quality data.


Summary: Join us at Eximia Research Network as we continue to grow, the Clinical Research Site Manager is responsible for the management of study team and the overall coordination and successful execution of all aspects of the assigned clinical trial(s) in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.


Key Responsibilities:

  • Work with the Regional Director of Operations to manage the operational budget and meet/exceed the siteโ€™s financial, operational, and study-specific targets.
  • Maintain complete (24/7) control over the overall operations and management of clinical research trials at the site
  • Identify and implement strategies to expand the research capabilities at the site - in line with the overall site business and growth plans
  • Oversee the implementation and maintenance of quality standards at the site ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs and SOPs
  • Work with the Medical Director to address any study and/or clinical quality related
  • Ensure timely and appropriate communications occur with Sponsors, CROs and IRBs as necessary
  • Develop site staffing plans to ensure the successful and efficient conduct of research studies. Identify and fulfil any site resource needs which are necessary to successfully conduct and/or recruit research studies.
  • Oversee the development of the patient recruitment plan and patient outreach process. Make ongoing adjustments/modifications to recruitment strategies based upon the timely review of results to ensure financial and study-specific targets. Closely collaborate with any external vendors to facilitate successful patient enrollment strategies.
  • Manage the performance of site staff members, delegating appropriate and challenging assignments to encourage growth, development and responsibility. Responsible for ensuring the ongoing training needs of site staff members are met.
  • Responsible for the assurance of all site staff complete required trainings.
  • Establish and communicate performance expectations and guidelines to site staff
  • Facilitate annual performance evaluation process with site staff.
  • Identify and manage issues, concerns and problems related to staff conduct
  • Identify and build relationships with outside medical practices, pharmacies, and other health care professionals/organizations to aid in the patient recruitment process.
  • Conduct business development activities on behalf of the site and with sponsors, CROs, CRAs and any third-party study vendors, as appropriate.
  • Responsible for overseeing the proper reporting of site revenues, preparation of financial projections, invoicing to sponsors/CROs, and A/R collections.
  • Ensure completeness, accuracy and timeliness of Feasibility Questionnaires, CDAs, CVs and essential regulatory documents from study start-up phase until site initiation.
  • Manage facility and IT needs to ensure smooth and efficient