Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary:

Functions as the primary contact for data management activities for all clinical trials. Ensures the timeline for database lock, the quality of the data, and the compliance of the data management documentation.

Primary Responsibilities:

• Designs and reviews the case report form, reviews annotated case report forms, and writes and reviews data management plans. Maintains the medical coding dictionaries/glossaries.

• Manages vendors/contractors related to data management activities.

• Coordinates the medical coding for adverse events, medical history, and concomitant medications.

• Maintains and updates MedDRA and WHO-DD dictionaries.

• Coordinates the SAE reconciliation between clinical database and the global drug safety database.

• Ensures consistency of clinical data standards across programs and therapeutic areas.

• Develops and streamlines the standard data management procedures.

• Provides expertise in the data management area to study managers, statisticians, and statistical/clinical programmers.

• Supports the (blind) data review and query/data reconciliations.

• Interacts with internal or external members of the clinical project team, including statisticians, data managers, and clinical research managers

Additional Responsibilities:

Clinical Data Manager 2

Leads meetings and conference calls with CROs, vendors, and multi-functional teams. Participates in the development of data management processes, working practices, and standard operating procedures.

Clinical Data Manager 3

Provides training to internal and external members of the project team. Assists with mentoring junior staff and is recognized as a subject matter expert on assigned studies.

Knowledge, Skills, & Abilities:

Clinical Data Manager 1

Basic knowledge of the clinical drug development process. Basic knowledge of both paper-CRF or electronic data capture (EDC) studies. Knowledge of MedDRA and WHO-DD and the medical coding process. Basic knowledge of MS Office. Good organizational and coordinating skills. Good verbal and written communication skills. Ability to be detail oriented with attention to follow up. Ability to multitask and prioritize work.

Clinical Data Manager 2

Good knowledge of the clinical drug development process. Good knowledge of both paper-CRF or electronic data capture (EDC) studies. Knowledge of MedDRA and WHO-DD and the medical coding process. Good knowledge of MS Office. Good organizational and coordinating skills. Good verbal and written communication skills. Ability to be detail oriented with attention to follow up. Ability to multitask and prioritize work.

Clinical Data Manager 3

Excellent knowledge of the clinical drug development process. Excellent knowledge of both paper-CRF or electronic data capture (EDC) studies. Knowledge of MedDRA and WHO-DD and the medical coding process. Excellent knowledge of MS Office. Excellent organizational and coordinating skills. Excellent verbal and written communication skills. Ability to be detail oriented with attention to follow up. Ability to multitask and prioritize work.

Requirements:

Clinical Data Manager 1

• Associate's degree in science or related field.

• Typically requires no previous related experience.

Clinical Data Manager 2

• Bachelor's degree in science or related field.

• Typically requires 2 years of related experience in CRO, pharmaceutical, or biotechnology industries.

Clinical Data Manager 3

• Bachelor's degree in science or related field.

• Typically requires 5 years of related experience in CRO, pharmaceutical, or biotechnology industries.

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Occupational Demands:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

EEO minorities/Females/Disability/Veterans

Learn more about Grifols (http://www.grifols.com/es/web/international/home)

Req ID: 501746

Type: Regular Full-Time

Job Category: Clinical Trials