Precision Medicine Group at a glance
Source: Wikipedia
Precision Medicine Group
- Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner
- May perform data entry for paper-CRF studies, as needed
- May perform quality control of data entry
- May provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed.
- Assist in developing CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
- May assist in building clinical databases
- Conduct database build UAT and maintain quality controlled database build documentation. May oversee overall quality of the clinical database.
- Assist in specifying requirements for all edit check types e.g., electronic, manual data review, edit checks, etc.
- Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
- Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
- Review and query clinical trial data according to the Data Management Plan
- Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
- Run patient and study level status and metric reporting
- Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
- Assist with coordinating SAE/AE reconciliation
- Assist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
- May assist with SAS programming and quality control of SAS programs used in the Data Management department
- Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
- May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
- May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
- Trains and ensures that all data management project team members have been sufficiently trained
- Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
- May present software demonstrations/trainings, department/company training sessions, present at project meetings
- May require some travel
- Perform other duties as assigned.
- 5+ years’ experience
- Bachelors and/or a combination of related experience
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
- Able to handle a variety of clinical research tasks.
- Excellent organizational and communication skills
- Professional use of the English language; both written and oral.
- Basic knowledge of drug, device and/or biologic development and effective data management practices.
- Experience in a clinical, scientific or healthcare discipline.
- Dictionary medical coding (MedDRA and WHODrug)
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
- Oncology and/or Orphan Drug therapeutic experience
- Motivates project team members to meet timelines and project goals
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
- Resolves project related problems and prioritizes workload to meet deadlines with minimal support
- Exhibits a high degree of self-motivation, and can work and plan independently as well as in a team environment
- Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.
Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.
To apply for this job please visit job-boards.greenhouse.io.
Explore Precision Medicine Group online
What people say about Precision Medicine Group
- AAAS: Machine learning 'causing science crisis'
- Personalized medicine: Time for one-person trials
- Ask HN: Who is hiring? (May 2015)
- Ask HN: Who is hiring? (April 2015)
Recent news
- Exclusive: Blackstone to test buyout market for PMG's CRO and pharma commercialization divisions, sources say - pehub.com
- Precision Medicine Group Launches Institute@Precision, a Collaborative Forum for Biopharma Innovation - PR Newswire
- Response to GLP-1 Weight Loss Drugs Varies Across Ancestry Groups - Inside Precision Medicine
- Longitudinal clinical trial enrollment trends across 341 US FDA-approved drugs and their guiding role in precision medicine strategies | Communications Medicine
- Stanford Medicine pilot program for precision health - Stanford Medicine
Aggregated from public discussions and news; opinions are the authors’ own.
Working in Bangalore, Karnataka
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Bengaluru, also known as Bangalore, is the capital and largest city of the southern Indian state of Karnataka. As per the 2011 census, the city had a population of 8.4 million, making it the third most populous city in India and the most populous in South India. The Bengaluru metropolitan area had a population of around 8.5 million, making it the fifth most populous urban agglomeration in the country. It is located towards the southern end of the Deccan Plateau, at an altitude of 900 m (3,000 ft) above sea level. The city is known as India's "Garden City", due to its parks and greenery.
Karnataka is a state in the southwestern coast of India. It was formed as Mysore State on 1 November 1956, with the passage of the States Reorganisation Act, and renamed Karnataka in 1973. The state is bordered by the Lakshadweep Sea to the west, Goa to the northwest, Maharashtra to the north, Telangana to the northeast, Andhra Pradesh to the east, Tamil Nadu to the southeast, and Kerala to the so
Source: Wikipedia (state)
Market context
- Similar listings in Bangalore, Karnataka, India 1
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