The Senior Clinical Data Manager (SCDM) handles all project management documentation, clinical data management activities, and system implementations for EDETEK’s eClinical, and may be assigned work on other platforms. This includes writing design specifications for the system (forms, reports, etc.) and facilitating testing of system implementations. The SCDM is also responsible for all other traditional clinical data management operations and activities such as facilitating database audits, coding, SAE reconciliation, system and module testing, data cleaning, and locking and unlocking of clinical databases. The SCDM is responsible for translating the client’s Clinical Data Management requirements and expectation into the DMP and implementing the clinical data management plans so that the clients expectations are met. The SCDM is responsible for the quality and integrity of the data in the final locked clinical database.
Ensure other Data Managers are trained and oversee the quality of all database start up standard essential documents and activities. Manage the work of outsourcing vendor and will approve the following key standard study documents: CCGs, Database clean plan, check validations, User Acceptance plans, eCRF development and DB lock plans.
The SCDM should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; have an understanding of the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.
Essential Functions and Responsibilities Support Internal Clinical Data Management Initiatives




Complete Traditional and Assigned Data Management Operations/Activities
Contribute to Project Success by Conducting Duties per CPM/LSCDM Request
Design Case Report Forms (CRFs)
Assist in the Development and Maintenance of Systems Used to Support Project Infrastructure
Work with Clinical Data Specialists (CDSs) to Execute Data Management Plans
Work with Clients/Sponsors as Necessary to Deliver Contracted Clinical Data Management Services and Clinical Data with High Quality and Integrity
Code Data per Selected Coding Dictionaries
Clean Data
Develop / Execute Testing Strategies
Assist with Data Transfers, Loading and Integration
Complete All Required Documentation per EDETEK and Project Requirements
Perform Use Acceptance Testing (UAT) on New Software
Classify Clinical Events per Agreed-upon Strategies/Plans Classification
Requirements
Ability to communicate effectively in the English language in person, by phone and in writing.
Ability to lead functional meetings
Strong attention to detail and accuracy is a must
Excellent organizational skills
Demonstrated ability to manage multiple projects
Ability to work collaboratively, effectively, and productively in diverse organization structures.
Ability to work independently, take initiative and complete tasks to deadlines: Delivering Excellence, Serving Customers, Accountability and Ownership, General and Cross-Functional Communication
Ability to work in a team-oriented,



collaborative environment.
Ability to work positively within a continually changing environment.
Ability to effectively prioritize and execute tasks in a high-pressure environment.
Advanced computer skills and practical knowledge of MS Office and potentially project management software.
Education and Experience Required A Bachelor’s degree or equivalent combination of Education/Training/Experience is required. A degree in a scientific, medical, or technological discipline is preferred.
A minimum of 2 years of clinical trial or clinical data management experience or similar industry experience/training is required.
Prior trial responsibility for the entire data management life-cycle is desirable.
Working knowledge of EDC studies and SAS is required.
Work Requirements Some travel (5%) may be required with a potential of travel occurring over weekends.
Cross-functional interactions
Benefits
Benefits vary by country
Location This is a remote position, and we are open to candidates based in Mexico, Argentina, and Brazil.
Equal Opportunity Employer Statement EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.

📌 Senior Clinical Data Manager (Ciudad de México)
🏢 Edetek
📍 Ciudad de México