Senior Clinical Data Coordinator require in Quintiles | Multiple vacancies

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.

Post: Senior Clinical Data Coordinator

Job Description:
PURPOSE
Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. Perform role of Data Team Lead (DTL). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

Client Management:
•Serve as primary point of contact for customer on data management deliverables
•With minimal guidance, provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
•With guidance, provide input for and perform direct negotiations with customer, e.g., timelines, financial, process, resources
•Maintain strong customer relationships
•Ensure open communications with customer and Quintiles management to manage and meet contractual obligations

Service Management:
•Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
•Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
•With minimal guidance, support DM service delivery with comprehensive DM process and technical expertise in executing projects
•Serve as the escalation point for unresolved data issues; with guidance, work with client data managers, vendors, internal team members for resolution
•Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables

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•With guidance, create and/or review and sign-off on all data management plan (DMP) documents
•Implement proactive quality management plan. Identify any service and quality issues with agreed upon specifications per the DMP and contract/SOW and work with functional manager(s) to resolve
•With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions
•Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
•Identify compliance issues and work with functional manager(s) to ensure timely follow-up and resolution
•With guidance, maintain internal tracking databases and systems

Financial Management/Business Development Support:
•With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW)
•Manage SOW/budget
-Review financial reports on a monthly basis and participate in project reviews as requested
-Identify out of scope tasks and track change orders to completion
•With guidance, may serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing
•With guidance, participate in and support RFP process (review RFP documents, pricing, attend bid defense)

Other:
•Provide input on DM process improvements or project solutions to CDM team/CDM department
•Provide input on the development and implementation of a new technology or tool
•Participate in a focus team or global or local best practice team
•Perform other duties as directed by functional manager(s)

Candidate Profile:
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
1. Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III)
2. Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)
3. Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
4. Knowledge of operating procedures and work instructions and the ability to apply them in practice
5. Knowledge of Good Clinical Practices and applicable regulatory guidelines
6. Excellent communication, interpersonal, customer service, and teamwork skills
7. Excellent organizational and problem-solving skills
8. Excellent project management skills
9. Ability to work with minimal supervision, using available resources, e.g., functional managers, senior DTLs
10. Comprehensive understanding of clinical drug development process
11. Ability to establish and maintain effective working relationships with coworkers, managers and customers

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
1. Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field, and a minimum of 5 years direct Data Management experience, including 3 or more years as a CDM project lead; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS
1. Extensive use of telephone and face-to-face communication requiring accurate perception of speech
2. Extensive use of keyboard requiring repetitive motion of fingers
3. Regular sitting for extended periods of time
4. Occasional travel is required

Additional Information:
Experience: Min. 5 Years
Location: Bangalore
Education: Bachelor's Degree in Health, Clinical, Biological or Mathematical Sciences
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job Code: 1201243
End Date: 6^th April, 2012