Work as Clinical Data Manager at PPD

 

PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients.

Post : Clin Data Mgr

Job Description :
The objective of a Clinical Data Manager I is to act as the lead data manager for one or more projects or to provide support to the lead data manager. CDM I's will lead all data management activities for individual, limited volume/complexity studies with mentoring from a manager as required. CDM I's work independently and efficiently perform, with quality, all data management activities within an assigned study. CDM I's may mentor junior level staff on all associated tasks within a study. CDM I's liaise with the sponsor as required and communicate with management regarding all data management activities within their studies. Responsibilities include:
• Ensures database accuracy according to departmental operating procedures
• Performs a QC review of the data and makes corrections to the DM database
• Develops data validation manual
• Defines and tests databases and data validation system
• Represents Data Management in all cross functional meetings relating to the study
• Reviews data listings for consistency and accuracy of data
• Develops and maintains data management project documentation files
• Performs independent reviews of data management deliverables following documented guidelines
• Acts as an interdepartmental and sponsor liaison for all DM study activities
• Produces project-specific status reports for management and sponsors
• Monitors study metrics
• Analyzes and resolves discrepancies in data validation or other reports

Candidate Profile
Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)3+ years work experience in a professional environment, preferably within a clinical or medical data environment, including 2 years of data management experience Or a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily Knowledge, Skills and Abilities: Knowledge of Oracle Clinical (preferred)Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations Strong attention to detail and skill with numbers Ability to use interactive computer programs Good written and verbal communication skills Good organizational and analytical/problem-solving skills Ability to work productively with minimal supervision Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data Ability to attain, maintain and apply a working knowledge of GCPs and applicable SOPs Strong customer focus and excellent interpersonal skills Ability to work in a team environment and independently as needed Ability to train and direct study teamMust demonstrate good judgment in making decisions Ability to travel to other locations as required or as business need dictates Must be able to set and meet timelines or be able to recognize and schedule changes in response to project demands Ability to identify potential out of scope activities to project and CDM management and to assist with the contract modification process Strong command of English language and grammar Working Conditions: Work is performed in an office/ laboratory and/or a clinical environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments and gloves.

Physical Requirements:
Ability to work in an upright and /or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance. Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

Additional Information
Experience : 2-5+ years
Qualification : B.Pharm
Location : Bengaluru
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clin Data
End Date : 15th July, 2019

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