Clinical Data Manager

This is a fully remote position, open to applicants in Brazil.

📋 Description

• The Clinical Data Manager (CDM) oversees project management documentation, clinical data management tasks, and system implementations for EDETEK’s eClinical, with potential assignments on other platforms.

• This role involves drafting design specifications for the system (forms, reports, etc.) and assisting in the testing of system implementations.

• The CDM is also tasked with all traditional clinical data management operations, including facilitating database audits, coding, SAE reconciliation, system and module testing, data cleaning, and managing the locking and unlocking of clinical databases.

• The CDM translates the client’s Clinical Data Management requirements and expectations into DMP and executes the clinical data management plans to ensure client satisfaction.

• The CDM ensures the quality and integrity of the data in the final locked clinical database.

• The CDM should possess a thorough understanding of Good Clinical Data Management services, including its documentation; be willing to engage in the start-up or wrap-up of both in-house and client-specific data management projects; have insight into relevant therapeutic indications, study hypotheses, and trial design; and maintain a solid understanding of database design and structure.

• Support Internal Clinical Data Management Initiatives.

• Execute Traditional and Assigned Data Management Operations/Activities.

• Contribute to Project Success by Performing Duties as per CPM/LSCDM Request.

• Design Case Report Forms (CRFs).

• Assist in the Development and Maintenance of Systems Used to Support Project Infrastructure.

• Collaborate with Clinical Data Specialists (CDSs) to Implement Data Management Plans.

• Work with Clients/Sponsors as Required to Provide Contracted Clinical Data Management Services and High-Quality Clinical Data.

• Code Data according to Selected Coding Dictionaries.

• Clean Data.

• Develop and Execute Testing Strategies.

• Assist with Data Transfers, Loading, and Integration.

• Complete All Required Documentation in Compliance with EDETEK and Project Standards.

• Conduct User Acceptance Testing (UAT) on New Software.

• Classify Clinical Events according to Agreed-upon Strategies/Plans Classification.

⛳️ Requirements

• Excellent communication skills in English, both in person and in writing, as well as via phone.

• Capability to lead functional meetings.

• Strong attention to detail and accuracy is essential.

• Exceptional organizational skills.

• Proven ability to manage multiple projects simultaneously.

• Competence in working collaboratively, effectively, and productively within diverse organizational structures.

• Ability to work independently, take initiative, and meet deadlines: Delivering Excellence, Serving Customers, Accountability and Ownership, Global and Cross-Functional Communication.

• Capacity to thrive in a team-oriented, collaborative environment.

• Adaptability to work positively within a continually changing environment.

• Proficiency in effectively prioritizing and executing tasks in a high-pressure setting.

• Advanced computer skills and practical knowledge of MS Office and possibly project management software.

• A Bachelor’s degree or an equivalent combination of Education/Training/Experience is required, with a preference for a degree in a scientific, medical, or technological field.

• A minimum of 2 years of experience in clinical trials or clinical data management or similar industry training is mandatory.

• Prior responsibility for the entire data management life-cycle in trials is desirable.

• Working knowledge of EDC studies and SAS is required.

🏝️ Benefits

• Options for comprehensive Medical, Vision, and Dental Insurance plans.

• Paid vacation time and sick leave.

• Annual corporate holidays.

• Participation in the 401K Plan.

• Extensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.

• Access to Health Advocate and Employee Assistance Program.