Clinical Data Manager

Clinical Data Manager

Department: Clinical Affairs

Employment Type: Full Time

Location: Gainesville, FL

Description

Responsible for the development, implementation, and management of databases and related data systems used to support clinical studies across Exactech's businesses. Ensure complete, accurate and consistent data is reported as required in a timely manner to regulatory bodies and for use in presentations and publications. Identify any areas requiring improvement in Exactech's clinical data management practices and implements solutions.

Key Responsibilities

• Lead the clinical data operations for Exactech to provide high quality clinical data management deliverables.

• Propose and establish best practices and ongoing strategies/needs for clinical data management. Educate and mentor team members on clinical data management best practices.

• Improve methods to organize clinical database information for effective analysis and evaluation of clinical data based on needs of the customer (e.g., regulatory bodies, clinical investigators).

• Execute the assessment, project planning, design, documentation, testing, and implementation of data collection systems and processes, including, but not limited to: source documents, case report forms, electronic data capture systems, databases, and/or data reporting systems in accordance with good data management practices, and all applicable regulations, guidelines, procedures and company policies.

• Act as a liaison and primary point of contact for all data management related issues and concerns, across Exactech's global businesses.

• Ensure data capture and maintenance will effectively meet the requirements of the protocol, expected project deliverables, and biostatistician requirements (if applicable).

• Coordinate and oversee all reporting activities to key stakeholders (within and outside the organization): Provide periodic data queries, reports and data summaries to Regulatory, Exactech management, Clinical Project Managers, and/or external team members as requested.

• Know and apply Exactech's Quality Management System and appropriate federal and international standards, including Good Clinical Practices.

• Support other employees, teams, and sales personnel as necessary.

• Practice Exactech Values.

Skills Knowledge and Expertise

Education:

• High School Diploma or GED required. Associate and/or Bachelor's Degree from an accredited institution preferred

Experience:

• Minimum 5 years relevant experience in clinical data management

• Experience in relational database development preferred

• Experience with SAS, SQL, R, or Python programming preferred

• SCDM Certification preferred

• Knowledge of applicable federal and international regulations and guidelines required

• Medical device industry experience preferred

Functional/Technical Knowledge, Skills and Abilities Required:

• Detail-oriented and strong organizational skills

• Familiarity with data acquisition platforms (EDC)

• Firm understanding of biostatistical concepts

• Strong data analysis skills

• Creative problem-solving and critical thinking skills

• Strong interpersonal communication skills

• Working knowledge of MS Office productivity software (e.g. Access, Word, Excel, PowerPoint)