Sr Clinical Data Analyst..Parexel .."R"

Designation	Sr Clinical Data Analyst
Job Description	Title: Sr Clinical Data Analyst Location: AS - India - Hyderabad Employment Type: Full Time Job Type: Regular Company Profile: Over the past 30 years, PAREXEL has developed significant expertise to assist clients in the worldwide pharmaceutical, biotechnology and medical device industries with the development and launch of their products in order to bring safe and effective treatments to the global marketplace for the patients who need them. Headquartered near Boston, Massachusetts, PAREXEL operates in 71 locations throughout 54 countries around the world, and has over 10100+ employees. We are a leading global bio/pharmaceutical services organization that helps clients expedite time-to-market through our development and launch services. These include a broad range of clinical development capabilities, integrated advanced technologies, regulatory affairs consulting, and commercialization services. For more information about PAREXEL International visit www.PAREXEL.com. Key Accountabilities - Assume the ability to meet the requirements of a CDA with a high degree of proficiency and autonomy - Take responsibility for specific tasks on projects, or acts as the main CDA contact on individual projects - Train team members on selected tasks - Prepare Data Cleaning Specification - Review the Data Validation Specification prepared by the Technical Analyst in GTS - Develop or provide input to project specific guidelines, e.g. SAE handling. - Initiate the running of study specific programs - 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 - If required liaise with 3rd party vendors to clean electronic data - 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 some interaction / supervision by Manager or assigned mentor Skills - Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, knowledge of MS-Office products such as Excel, Word - Sound awareness of all relevant regulations, including GCP - Ability to successfully work in a (virtual) team environment - Client focused approach to work - Effectively applies knowledge to provide advice or solutions based on expertise - Offers support and constructive feedback to project team members - Seeks opportunities to develop experience and knowledge - Ability to organize and plan tasks - Excellent interpersonal, verbal and written communication skills - Must be able to work independently but seek guidance when necessary, escalating issues as required - 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 - Willing and able to travel as required local or international Experience - 6 to 9 years of Minimum Relevant Clinical Data Management Experience - Minimum of Graduation in Life Sciences of equivalent experience - Fluent in English
Desired Profile	Please refer to the Job description above
Experience	5 - 10 Years
Industry Type	Pharma / Biotech / Clinical Research
Role	Team Lead/Technical Lead
Functional Area	IT Software - Application Programming, Maintenance
Education	UG - Any Graduate - Any Specialization, Graduation Not Required PG - Any Postgraduate - Any Specialization, Post Graduation Not Required
Location	Hyderabad / Secunderabad
Keywords	CDA, Clinical data analyst, EDC, Clinical Data Management
Contact	PAREXEL International (India) Pvt Ltd
Website	https://parexel.com
Job Posted	29 Nov