You have opted out of job matches in .
To undo this, go to the 'Skills and Interests' section of your preferences.
Shared by 
9 days ago
warning
Heads-up
Requirements and responsibilities
The Clinical Data Manager (CDM) handles 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 CDM 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 CDM is responsible for translating the client’s Clinical Data Management requirements and expectations into DMP and implementing the clinical data management plans so that the clients’ expectations are met. The CDM is responsible for the quality and integrity of the data in the final locked clinical database. The CDM 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 ResponsibilitiesSupport Internal Clinical Data Management InitiativesComplete Traditional and Assigned Data Management Operations/ActivitiesContribute to Project Success by Conducting Duties per CPM/LSCDM RequestDesign Case Report Forms (CRFs)Assist in the Development and Maintenance of Systems Used to Support Project InfrastructureWork with Clinical Data Specialists (CDSs) to Execute Data Management PlansWork with Clients/Sponsors as Necessary to Deliver Contracted Clinical Data Management Services and Clinical Data with High Quality and IntegrityCode Data per Selected Coding DictionariesClean DataDevelop / Execute Testing StrategiesAssist with Data Transfers, Loading and IntegrationComplete All Required Documentation per EDETEK and Project RequirementsPerform Use Acceptance Testing (UAT) on New SoftwareClassify Clinical Events per Agreed-upon Strategies/Plans Classification.RequirementsAbility to communicate effectively in the English language in person, by phone and in writing.Ability to lead functional meetingsStrong attention to detail and accuracy is a mustExcellent organizational skillsDemonstrated ability to manage multiple projects6. 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, Global and Cross-Functional CommunicationAbility 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 RequiredA 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 RequirementsCorporate office environment or remote.Some travel (5%) may be required with a potential of travel occurring over weekends.Cross-functional interactionsBenefitsBenefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees.Choice of comprehensive Medical, Vision and Dental Insurance plansPaid vacation time and sick daysCorporate holidays annuallyParticipation in the 401K PlanComprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.Health Advocate and Employee Assistance ProgramLocationThis is a remote position, and we are open to candidates based in the United States and South America.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.
Optionally, you can add more information later (benefits, pre-screening questions, etc.)