Immediate Need -- Clinical Data Analyst @ Billerica, MA (Very Hot Requirement)

[Mark Evans]

Dear Associate,

Wishes for the day,

We need a strong Clinical Data Analyst with Clinical and Pharmaceutical experience

Please share suitable profiles to mark....@panzersolutions.com

Job Title : Clinical Data Analyst

Location : Billerica, MA

Duration : 6+ Months Contract (Extendable upto 2 Years)

 

Must have CDM experience on resume and in "titles"

The role of the Clinical Data Analyst (CDA) II is to perform all clinical data cleaning activities on assigned projects, commensurate with experience and/or project role.  

 

Key activities include data validation, generation and integration of queries, coding of clinical data, reconciliation of safety and electronic data. 

The Clinical Data Analyst will assume the Clinical Data Manager responsibilities on studies 

Comply with Company policies, SOPs and Regulatory guidelines. 

Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines etc. 

Conduct in-house data review 

Generate and close queries or apply self evident corrections to the data according to the relevant guidelines 

Identify and report protocol violations 

Manual and Patient Profile review, issue queries 

Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action 

Track and integrate queries 

Perform clinical coding if appropriate to role within the project team 

Ensure all documents coded for submission to central files 

Lock site(s) within EDC system - remove user's data modification privileges 

Interact with site (via mail) as required 

Perform early and final database QC activities 

Update all relevant tracking system on an ongoing basis 

Inform responsible CDA coordinator of work status regularly 

Keep manager informed about work progress and any issues to avoid surprises. Requires regular interaction / supervision by Manager or assigned mentor 

Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and  WSOP and stud specific procedure 

Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims 

Good computer skills including but not limited to the knowledge of 

Clinical Trial/Data Management Systems, PMED, MS-Office products such as Excel, Word. 

Demonstrate a sound awareness of all relevant regulations, including GCP 

Ability to successfully work in a ('virtual') team environment 

Client focused approach to work 

If required, knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG) 

Solid interpersonal, verbal and written communication skills

Sense of urgency in completing assigned tasks 

Meticulous attention to detail 

Effective time management in order to meet daily metrics or team objectives 

Shows commitment to and performs consistently high quality work 

 

Education 

Bachelor's degree and / or other medical qualification or relevant DM experience 

 

Language Skills 

Competent in written and oral English

Thanks

Mark Evans | Technical Recruiter

Direct: 203-652-7131

Work: 203-652-1444 Ex No : 105

E-mail: mark....@panzersolutions.com