Clin Data Assoc II | J296

Clin Data Assoc II | J296

27 dic
Ciudad de México

27 dic


Ciudad de México

Summarized Purpose :

Performs advanced aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs / WPDs, to assess the safety and efficacy of investigational products and / or medical devices.

Essential Functions :

Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required.

Generates, tracks and resolves data clarifications and queries. May implement CRF design in identified graphic design package.

Reviews data listings for accuracy and consistency of data. Analyzes and resolves data validation and other data management reports.

Produces project-specific status reports for CDM management and for clients on a regular basis.

Performs data management activities such as Serious Adverse Event and Third-Party Vendor reconciliations as well as Data Listing reviews.

Job Qualification

Education / Experience :

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Technical positions may require a certificate

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and / or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills & Abilities :

Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations

Strong attention to detail and skill with numbers and ability to use interactive computer programs

Good written and verbal communication skills and a strong command of English language and grammar

Good organizational and analytical / problem-solving skills

Ability to work productively with moderate supervision

Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data

Strong customer focus and excellent interpersonal skills.

Proven flexibility, adaptability and ability to work in a team environment or independently as needed

Must demonstrate good judgment in making decisions

Knowledge of medical / clinical trial terminology

Understands project protocol and Data Validation Manual

Working Environment :

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

Below is listed the working environment / requirements for this role :

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. 10-20% annual possible.

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