Clinical Data Manager I

About the Role:

The Clinical Data Manager will assist in all activities for the global clinical study data management process from start-up to database lock and regulatory submission support. This individual will aid in ensuring clean and valid clinical study data is delivered to biostatistics, through the EDC build, programming of edit checks, cleaning and performing all data management activities for the life-cycle of a study. This position will help coordinate activities with CROs, other external vendors, database programming and trial operations to define and implement data management requirements. 

Responsibilities:

• Assist with EDC database design (form design and edit check programming) and setup at the protocol level 
• May work closely with CROs during the design and development of eCRFs, CRF completion guidelines, edit checks and data management plans 
• Participates in UAT for each database build and work with vendor to understand the impact of all mid-study updates to the database 
• Participates in data cleaning, via patient profiles and listings, on an ongoing basis 
• May issue queries and provide report trends to the internal teams and CROs 
• Assists in ensuring the deliverables of external data management vendors are quality, complete and adhere to timelines 
• Participates in reconciliation activities between the safety and clinical database on ongoing basis 
• Creates data management plans and documentation as applicable
• Perform other duties and responsibilities as assigned 

About You:

Education:

• Bachelors Degree in Life Science or related field.

Experience: 

• 2+ years Clinical Data Management experience 
• 3 years of combined Data Management and other clinical experience preferred  
• Experience with Medidata Rave 

Skills:

Technical: 

• Working knowledge of industry standards, such as CDISC/SDTM 
• Basic understanding of SAS, SQL and/or other clinical programming 
• Basic understanding of application of clinical data coding classification systems, e.g., MedDRA, WHO-Drug 
• Good working knowledge of GCP and ICH guidelines, and Good Clinical DM practices 
• Solid computer/analytical skills 
• Proficient in Microsoft Word, Excel and PowerPoint 

Communication: 

• Excellent written and verbal communication  
• Must be able to interact and liaison effectively with people at all levels of the organization and with external vendors, investigators, site personnel, etc. 

Other: 

• Detail-oriented and well organized 
• Understanding of steps required to set up and successfully manage delivery of Phase 2-4 studies 

The expected salary range for this position is $85,000 - $113,000.  Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.