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Associate Clinical Study Manager Jobs in Georgia

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Associate Clinical Study Manager information

What is an associate clinical study manager?

Associate Clinical Study Managers are professionals who support the planning, execution, and management of clinical trials in the pharmaceutical, biotechnology, or medical device industries. They work closely with Clinical Study Managers and other team members to ensure studies are conducted in compliance with regulatory guidelines and timelines. Their responsibilities often include overseeing documentation, coordinating with study sites, tracking study progress, and assisting with data management. This role is essential for ensuring that clinical studies run smoothly and efficiently, contributing to the development of new treatments and therapies.

What are the key skills and qualifications needed to thrive as an associate clinical study manager?

To thrive as an Associate Clinical Study Manager, you need a solid understanding of clinical trial processes, regulatory guidelines, and project management principles, often supported by a degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and Good Clinical Practice (GCP) certification is typically required. Strong organizational skills, attention to detail, and effective communication are essential soft skills for coordinating study activities and collaborating with cross-functional teams. These skills ensure clinical studies are conducted efficiently, compliantly, and with high data integrity.

What are the main challenges an associate clinical study manager faces when coordinating multiple clinical trials simultaneously?

As an Associate Clinical Study Manager, balancing multiple trials often involves managing tight timelines, ensuring regulatory compliance, and coordinating with cross-functional teams such as data management, regulatory affairs, and site staff. Juggling these responsibilities can be challenging, especially when unexpected issues arise at different study sites or timelines shift. Strong organizational skills, proactive communication, and adaptability are key to effectively managing these complexities and keeping studies on track.

What is the difference between Associate Clinical Study Manager vs Clinical Study Coordinator?

AspectAssociate Clinical Study ManagerClinical Study Coordinator
ResponsibilitiesOversees study operations, manages teams, ensures compliance, and supports study planningCoordinates daily study activities, manages participant scheduling, and assists with data collection
Required CredentialsBachelor’s degree in life sciences, clinical research experience, often some project management knowledgeBachelor’s degree, clinical research or healthcare background, strong organizational skills
Work EnvironmentTypically in clinical research teams within pharmaceutical or biotech companiesOften in clinical sites or research facilities, supporting study execution
Industry UsageCommonly in pharmaceutical, biotech, and CRO settingsPrimarily in clinical research sites and hospitals

The Associate Clinical Study Manager and Clinical Study Coordinator roles share similarities in supporting clinical trials, but the manager has broader oversight and leadership responsibilities. The coordinator focuses on daily operational tasks, while the manager oversees study progress and compliance.

Associate Clinical Study Manager jobs near you

Clinical Research Associate (CRA) -Cardiovascular Medical Device

Marietta, GA • On-site

Mirus LLC
1 - 10 employees
Learn more about Mirus LLCexternal

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 25 days ago

Job description


Role: Clinical Research Associate (CRA) - Cardiovascular Medical Device 

Location: Remote  

Position Summary: 

Assist with the management of cardiovascular clinical studies for MiRus products with a focus on adherence to critical timelines, high-caliber document development and quality data collection. The applicant should possess strong critical thinking skills and the ability to comprehend technical subject matter to effectively contribute to the organization.

Essential Duties and Responsibilities:
 

  • Contribute to content generation, writing and editing of study protocols, amendments, informed consents, committee charters, study reports, monitoring plans, and other related clinical and regulatory documents.
  • Assist with the management of investigational studies from start through study closure.
  • Engage in new study trial design with cross functional teams, including clinical and pre-clinical research and development groups.
  • Contribute to the development of CRFs
  • Assist with the formulation of instructional materials and training of investigators, study coordinators and associated study site personnel on the conduct of the clinical trials, as applicable.
  • Assist Study Manager with safety monitoring including preparing supporting documentation for CEC and/or DSMB, meetings, agenda, data review, presentations, and updating relevant trackers as applicable.
  • Serve as a point of contact between clinical site investigators and the MiRus team.
  • Work with investigators and site personnel to quickly and effectively resolve discrepancies.
  • May be responsible for patient accruals and tracking payments to sites for clinical study programs
  • Serve as a point of contact between CRO personnel and MiRus.
  • Oversee/support CRO and field study monitors, with monitoring related items and follow-up on study tasks.
  • Monitor ongoing compliance to study protocols in accordance with applicable regulations and GCP, work instructions, guidelines and/or policies.
  • Provide continuous data review of source documents, case report forms, data reports as appropriate.
  • Assist in review of monitoring reports and tracking of action items.
  • Review source documentation to confirm subject eligibility for clinical trials.
  • Track and upload study imaging
  • Manage clinical study documentation (trial master file and study related tracking).
  • Update and design as needed study dashboards, study trackers and other applicable study documents to provide regular updates on trial status to Study Manager
  • Interact with data management, as applicable
  • Support applications and technical files as needed.
  • Assist with preparation for investigators meetings.

 Minimum Education and/or Experience: 

  • Bachelor’s or Master’s degree in nursing with clinical experience in the cardiac field (CCU, CVOR, Cath Lab) and experience in a clinical research role.  CRA certification desired.
  • At least 2 years of experience in clinical research role, with at least 2 years in CRA role, preferably in cardiovascular medical device.
  • Experience in clinical trials and/or post-market registries in the U.S., Australian and/or European Union, with other geographies desired.
  • Current knowledge of medical device clinical trials design and best practices.
  • Proficient knowledge of FDA regulations and ICH/GCP guidelines, guidance documents, and other applicable regulations and standards, and implementation of these standards in the medical device industry, in the U.S. and all countries in which trials are conducted.
  • General application of medical terminology (cardiovascular specific preferred).

 Benefits:
MiRus offers competitive compensation, options, full benefits, and relocation assistance.

  •  401(k)
  •  Dental insurance
  • Vision insurance
  •  Disability insurance
  •  Employee assistance program
  •  Flexible spending account or Health Savings Account
  •  Health insurance
  •  Life insurance
  •  Paid time off

 Schedule:

  • Monday to Friday (8am – 5pm)

Work Location:

  • Remote
  • Position may require domestic travel at least 20-40%