Rajendra Babu Bolineni

Deputy General Manager experienced in planning, directing and managing company work activities, functions and operations. Documented history of facility management and operations to fulfill organization contractual obligations, quality standards and performance objectives. Provides expert direction and guidance to subordinates and formulates work plans. Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.

• Best Employee of the year 2013-2014
• Star Performer of the year 2014-2015
• Best Team of the year 2014-2015
• Featured in MaxisIT Inc. Website.

• Good knowledge on ICH- GCP guidelines, clinical trials, and FDA Regulations
• Possesses a good understanding of the clinical data management systems and processes.
• Take initiative and have a flexible approach with respect to assignments and new learnings.
• Knowledge of Company policy, procedures, and organizational structure
• Taking complete ownership on Quality of Deliverables, training needs, and sharing best practices with the team and acts as a Subject Matter Expert.
• Good knowledge and experience in CDISC Standards.
• Expertise in CDISC-SDTM, ADaM data conversion process and Knowledge on Tables, Listings
• Reviewing trial related documents (CRF, Protocol, Raw data) and SAP (statistical analysis plan)
• Performing data import and data transformation activities for clients
• Worked on Phase-I, II and III studies of Oncology, Neurology, and Immunology therapeutic area.
• Excellent communication (both verbal and written) and interpersonal skills.
• Strong analytical skills with a clear focus on end objectives
• Possesses attention to detail and good problem-solving skills.

Ability to fill Statistical Programming Lead role on projects.

Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. 

Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget. 

Monitor project resourcing, project budgets, and identify changes in scope. 

Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. 

Collaborated with cross-functional teams to develop innovative solutions. 

Interact with sponsors and internal stakeholders regarding statistical programming issues. 

Assisted with day-to-day operations, working efficiently and productively with all team members. 

Introduced new methods, practices, and systems to reduce turnaround time. Deliver best value and high-quality service. 

Check own work in an ongoing way to ensure first-time quality. 

Use efficient programming techniques to produce/QC derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings. 

Produce/QC dataset specifications and other process supporting documents and submission documentation.

Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements.

Use critical thinking to break down problems, evaluate solutions and make decisions. 

Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, and electronic submissions).

• Passport Number: S5077997 (Have valid B1 for USA)
• Father's Name: Satyanarayana Bolineni
• Marital Status: Married
• Date of Birth: 07/07/86
• Nationality: Indian