Clinical Data Coordinator

Description:

Job Summary:

Working under general supervision is responsible for most aspects of data management activities in support of assigned clinical studies.

These activities help to ensure high quality data is achieved in support of analysis for regulatory submissions safety monitoring and publications.

Ensures that Good Clinical Practices GCP Good Clinical Data Management Practices GCDMP and established processes are followed.

Identifies and routinely uses the most effective cost efficient and best business practices to execute processes continually evaluates their effectiveness and appropriateness.

Exercises judgment in planning organizing and performing work monitors performance and reports status within area of responsibility.

Ensures that quality of services meets internal and external customer requirements.

With appropriate manager oversight performs all data management activities for assigned studies o Case Report Form CRF development and maintenance

o Edit Check specifications development and maintenance

o Data Management Plan development and maintenance

o Analyzes data identifies trends prepares data tables for clinical reports

o Database setup testing and Edit Check programming testing

o Elements of device reconciliation

o Participate in Post Market Surveillance reporting as appropriate

o Additional study specific activities Ensures that all data management activities for assigned studies are completed on time and with high quality or escalates as appropriate

o Case Report Form CRF development and maintenance o Edit Check specifications development and maintenance

Communicates well with peers study teams and management as appropriate to support studies and goals Represents the Data Management group at study team meetings

Applies best practices and established standards Has a general understanding of the clinical trial process and regulations that apply engages in relevant professional associations or societies and seeks continuing education about SJM devices and therapies.

Support all Company initiatives as identified by management and in support of Quality Management Systems QMS Environmental Management Systems EMS and other regulatory requirements.

Performs other related duties and responsibilities on occasion as assigned.

Experience Level:

Entry Level

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.