PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations.
Job Title : Clinical Data Associate II
Job ID – 135084
Job Description :
Due to continued growth, PPD is expanding our Clinical Data Management department in Smolensk. This is an exciting opportunity to join a multinational American based CRO that is growing and expanding in Russian Federation. Joining our global clinical Data Management team, we offer more than regular Clinical Data Management. We bring a deep understanding of the science of disease and compounds, as well as provide valuable upfront study design and comprehensive planning assistance to our global client base.
Key Responsibilities :
- The objective of a Clinical Data Associate II is to perform advanced aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs/WPDs, in order to assess the safety and efficacy of investigational products and/or medical devices.
- Clinical Data Associate IIs are expected to perform the tasks of a Clinical Data Associate I with increased efficiency, while maintaining a high level of accuracy, and to work more independently.
- In addition they will be expected to perform data management activities such as Serious Adverse Event and Third Party Vendor reconciliations as well as Data Listing reviews.
Qualifications
- 2-3 years of experience in Clinical Data Management
- Bachelors/ Master’s degree in life Sciences
Required :
- Proven ability in achieving applicable technical competencies per the CDM competency grid.
- Ability to effectively apply 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.
- Ability to use interactive computer programs.
- Excellent English – both written and verbal.
- Good organizational skills
- Good 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.
