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Clinical Development Biotech Jobs in Tennessee (NOW HIRING)

We serve more than 400 pharmaceutical, biotechnology, and device organizations The Clinical Project ... Collaborating with BD Director in the development and presentation of company capabilities calls ...

Job Overview The Clinical Research Associate I (CRA I) plays a key role in supporting the ... We create intelligent connections to accelerate the development and commercialization of innovative ...

CRA 1, IQVIA Biotech

Elizabethton, TN · On-site

$71K - $145K/yr

Job Overview The Clinical Research Associate I (CRA I) plays a key role in supporting the ... We create intelligent connections to accelerate the development and commercialization of innovative ...

CRA 1, IQVIA Biotech

Elizabethton, TN · On-site

$71K - $145K/yr

Job Overview The Clinical Research Associate I (CRA I) plays a key role in supporting the ... We create intelligent connections to accelerate the development and commercialization of innovative ...

CRA 1, IQVIA Biotech

Franklin, TN · On-site

$71K - $145K/yr

Job Overview The Clinical Research Associate I (CRA I) plays a key role in supporting the ... We create intelligent connections to accelerate the development and commercialization of innovative ...

Hybrid Virtual Bilingual Clinical Educator

Nashville, TN · On-site

$81K - $150K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Inizio Engage has a long-standing partnership with a leading Biotechnology company, across ... The VCE also supports the design and development of TA educational resources, including disease ...

Biospecimen Project Manager

Johnson City, TN · On-site +1

  • Medical

  • Life

  • Retirement

  • PTO

Overview LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.

Biospecimen Project Manager

Johnson City, TN · On-site +1

  • Medical

  • Life

  • Retirement

  • PTO

Overview LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.

Biospecimen Project Manager

Johnson City, TN · On-site +1

  • Medical

  • Life

  • Retirement

  • PTO

Overview LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.

Clinical Educator

Nashville, TN · On-site

$84K - $156K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

InizioEngage has a long-standing partnership with a leading Biotechnology company, across ... Tofacilitatethe development and provision of services across multiple healthcare sectors ...

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Showing results 1-20

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 key skills and qualifications needed to thrive as a clinical development professional in biotech?

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 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 popular job titles related to Clinical Development Biotech jobs in Tennessee?

For Clinical Development Biotech jobs in Tennessee, the most frequently searched job titles are:

What job categories do people searching Clinical Development Biotech jobs in Tennessee look for?

The top searched job categories for Clinical Development Biotech jobs in Tennessee are:

What cities in Tennessee are hiring for Clinical Development Biotech jobs?

Cities in Tennessee with the most Clinical Development Biotech job openings:

Clinical Project Manager

Bioclinica

Franklin, TN • On-site

Full-time

Re-posted 16 days ago


Job description

Company Description
Bioclinica is one of the leading global CRO company which focuses on bringing efficiency to the clinical trials. We have a premier global research network-and the only one with investigator sites in the U.S., Europe, Latin America, and Asia. We are headquartered in Doylestown, PA. Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division. We serve more than 400 pharmaceutical, biotechnology, and device organizations
Job Description
The Clinical Project Manager will focus on study start up through close out activities and perform project analysis while highlighting leadership skills in therapeutic areas such as Neuroscience, Musculoskeletal, Oncology, Cardiovascular, and more. This individual would be driven, dedicated and adaptable in a fast-paced environment. Project Management experience within a CRO is highly desirable.
Primary Responsibilities
Identifies project guidelines and communication needs by:
  • Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documents
  • Defining project plans (i.e. timelines, milestones and limitations for project staff)
  • Establishing project reporting schedules
  • Providing project updates to BD Director, Global Services Managing Directors, Sponsor representative(s) on schedule
  • Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s)

Performs project analysis and management by:
  • Identifying critical project success factors for tracking, analysis and reporting
  • Determining needed resources for project completion and communicating needs to appropriate departmental managers
  • Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project
  • Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost management
  • Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting
  • Understanding SOPs and working closely with QA for clarification and documentation of deviations
  • Training and maintaining project team knowledge and applications of SOPs
  • Communicating all protocol clarifications/revisions to project team
  • Coordinating site management of data collection with internal and external teams

Provides project team leadership by:
  • Leading by example with professional and collaborative conduct
  • Developing and delivering team project training
  • Establishing team performance expectations and guidelines
  • Providing input to departmental managers of respective team members' performance level
  • Analyzing team performance for consistency/quality within established project guidelines
  • Collaborating with the departmental managers for team coaching/mentoring

Supports Business Development efforts by:
  • Collaborating with BD Director in the development and presentation of company capabilities calls/meetings
  • Attending professional meeting(s) as Company representative
  • Delivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company services

Oversees project close out by:
  • Assisting with coordination of submission activities, as applicable
  • Assisting with initiating and overseeing all project close out activities to completion

Performs supervisory functions by, if applicable:
  • Communicating job expectations
  • Planning, monitoring and appraising job results
  • Coaching, counseling and disciplining staff
  • Initiating, coordinating and enforcing systems, policies and procedures
  • Approving direct reports time sheets, requests for time off and/or overtime
  • Performing timely performance evaluations of direct reports
  • Coordinating and conducting new hire interviews; facilitating hiring decision
  • Training new hires on departmental processes and responsibilities

Maintains Quality Service and Departmental Standards by:
  • Reading, understanding and adhering to organizational Standard Operating Procedures ("SOP")
  • Establishing and enforcing departmental standards
  • Reviewing and updating company SOPs related

Secondary Responsibilities
Contributes to team effort by:
  • Exploring new opportunities to add value to organization and departmental processes
  • Helping others to accomplish results
  • Performing other duties as assigned and deemed necessary

Maintains Technical Knowledge by:
  • Attending and participating in applicable company sponsored training

Qualifications
Education:
  • Bachelor's degree required or commensurate experience level. Educational majors in life sciences, pharmacy, nursing, or other healthcare field highly desirable

Experience:
  • Previous management or project experience in clinical development of investigational medications required
  • 1-3 years clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a project management related role.
  • Working knowledge of GCH, ICH guidelines and FDA regulations
  • Medical Imaging experience a plus
  • Experience working with computer software including Word, Excel, Access and Project preferred

Additional skill set:
  • Strong interpersonal and communication skills, both verbal and written
  • Strong organizational and leadership skills
  • Goal oriented
  • Ability to maintain professional and positive attitude

Additional Information
Working conditions:
  • Travel: 0-20%
  • Lifting: 0-15lbs
  • Other: Computer work for long periods of time

EEO Statement
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic