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: Manager, Technical Operations - Bangalore-115616
Job Description
Due to continued growth, PPD is hiring a Manager, Technical Operations to be based in Bangalore to support our global projects. This is an exciting opportunity to join a multinational American based CRO that is growing and expanding in India. Joining our global Data Management team, we employ the technology, processes and expertise that best meet the needs of our client’s project with PPD’s Clinical Data Management solutions. Across a broad range of therapeutic areas and quantitative methods, PPD has extensive data management experience for Phase I-IV clinical trials.
The objective of the Manager, Technical Operations is to manage the day-to-day operations for the Technical Operations group within Clinical Data Management and the resources and workload of direct reports.
Duties and Responsibilities of the Technical Operations Manager will include:
- Manages or performs tasks associated with the completion of one or more Technical Operations deliverables or the administration of processes and systems supporting these deliverables. Ensure staff compliance with documented procedures and manage staff to established timelines and budget. Ensure appropriate customer service/communications.
- Identifies, supervises, trains, and provides performance feedback for Technical Operations staff.
- Leads/Participates in the creation and validation of reporting tools / standard applications / processes
- Serves as Technical Operations Lead on Study specific database design / build activities
- Reviews designs for compliance/feasibility within the database system and consistency with any current standards and/or sponsor specifications.
- Meets with study teams on a regular basis during initial study setup to ensure effective communication and accuracy in design
- Designs, annotates and builds databases within the timelines established by the team and indicated by the contract.
- Develops and validates data validation checks
- Coordinates the activities of other Technical Operations staff that might assist in building studies to ensure all jobs are carried out and timelines are met.
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Qualifications
- Degree qualified in computer science, statistics, biostatistics, mathematics, biology or related fields.
- 5 years’ experience in clinical trials environment
- 3 years’ experience with EDC (Electronic Data Capture) applications in a programming or administration capacity.
- Minimum of 1 year experience in a team leadership/supervisory role
- Knowledge of relational database systems (RDBMS) and structures
- Experience in Oracle and with Oracle tools or similar systems
- Previous experience from a CRO, or a mixture of Pharmaceutical and CRO experience
- Good organizational skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
- Good interpersonal skills including problem solving
- Demonstrated experience in identification and resolution of technical problems in a professional environment
- Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others.
- Must be able to set and meet timelines or be able to negotiate schedule changes in response to project demands
Additional Information:
Experience: 3-5 Years
Location: Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Other
Job Code: 115616
End Date: 25th May, 2014
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