Clin Data Assoc Ii

3 weeks ago

Bengaluru, India Thermo Fisher Scientific Full time

Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.Are you a data and a people person? Here’s your team. We manage and clean the data collected in a clinical trial — from the design and build of the database and edit checks, through the entry and cleaning of data to the final delivery of clinical trial data. We work closely with the project teams and clients to identify best practices and processes, meet and exceed our clients’ needs, and do the right thing to earn their trust.As a Clinical Data Associate II, you will help ensure the highest quality of data and effectiveness of CDM Projects. You will work to provide data entry and validation of CDM projects within a fast-paced environment.At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.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.- Education/Experience:
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualificationTechnical positions may require a certificatePrevious 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.PPD Defining Principles:
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD

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