Skills & Qualifications:

Required Qualifications:

• Bachelor’s Degree

• Minimum of five years of related experience, ideally in a clinical research environment and/or in clinical study management.

• Understanding of GCP and 21 CFR 812

Preferred Qualifications:

• Experience with building clinical databases and data analysis

• Minimum of ten years of related experience, ideally in a clinical research environment

• Experience with US and international based clinical studies

Experience Level:

Expert Level

Description:

Responsibilities:.

• Responsible for managing clinical studies in accordance with internal standard operating

procedures and applicable regulations and guidelines

• Strategically plan, sequency, and scope clinical studies to build clinical evidence to support

therapy adoption

• Collaborate with internal and external clinical team members, consultants, and/or CROs to

draft clinical study protocols, Instructions for Use, Report of Prior Investigations,

Investigational Brochures and other clinical study documentation

• Oversee clinical site selection and activation

• Manage study safety by tracking and reporting adverse events as required by regulatory

bodies, reviewing adverse event trends, and overseeing safety committees including Clinical

Events Committees and Data Safety Monitoring Boards

• Oversee monitoring activities related to assigned clinical studies including review and

approval of monitoring plan and monitoring reports, managing monitoring schedule and

ensuring corrective action related to monitoring findings

• Develop training plans for study training and review/approve training documentation

• Prepare study-related reports including annual, interim and final study reports

• Organize and lead study-related conference calls and Investigator meetings as needed

throughout the study

• Oversee investigational device allocation, distribution and reconciliation

• Collaborate with data management team to ensure appropriate data capture and query

management

• Assist with and/or perform data analysis

• Ensure proper closeout and archiving of data management study related materials, i.e.

database change documentation, validation documents, and final patient casebooks in paper

or electronic format;

• Build effective working relationships with team members

• Document product and therapy related field reports within the prescribed timelines and

provide any necessary documents required to complete the investigation. Provide follow-up

reporting as needed.

• Complete training requirements and competency confirmations as required for this position

within the required timeline.

• Comply with applicable quality system procedures/policies and make suggestions for

continuous process improvement

Skills:

Clinical research, Clinical trial management, Clinical project management, Medical device, Budget management, CRO, Vendor management

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.