Vasta Bio-Informatics - AVP - Quality & Technical - US Healthcare/Oncology Projects

AVP - Quality and Technical

About us (VASTA BIOINFORMATICS PVT Ltd. - VBPL):

We are headquartered in New York, USA committed to provide sustainable and scalable solutions for your clinical research and bioinformatics needs. Our team has almost a decade worth of experience in medical information management especially cancer research. Good data drives quality research. We recognize that today's research will shape the clinical practice guidelines of tomorrow. Our information technology and data management solutions can streamline and integrate research and patient care workflows to collect quality data and achieve research goals.

Job Title: Assistant Vice President (AVP)

Department: Quality and Technical

Job Location: Navi Mumbai

Reporting To: CEO

Job Summary:

- The AVP - Quality and Technical is responsible for leadership and direction of all aspects of the Quality Assurance function and Technical Team, to ensure appropriate level of compliance of the company's activities with recognized regulations and guidelines.

- The incumbent will establish quality plans and policies and report compliance activities and findings to Executive leaders on a regular basis. This individual will design, implement and maintain QA and compliance programs and infrastructure - including an SOP system and training program  and perform internal audits.

- The person will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance. They will also serve as an in-house advisor on company's compliance.

- On technical front will be responsible for overseeing, implementing, preparing, conducting, and evaluating technical training teams and programs in the field of medical oncology data management. Writing literature and materials to be used in programs and designs exercises to enhance lectures. Conducting classes for trainers regarding general medical and oncology, subtype specific training, training best practices.

Job Duties / Responsibilities :

- Design and maintain Quality Assurance and compliance and handle technical team for all aspects of organization's programs

- Lead, manage and mentor a large team of QA professionals and Technical professionals with varying degrees of experience and expertise

- Maintenance of quality and technical agreements

- Write, review, approve and maintain Standard Operating Procedures

- Responsible for deviations, complaint investigations and archives

- Ensure training programs throughout organization meet quality standard requirements

- Direct development and implementation of quality and technical systems to ensure projects reliability, quality, efficacy, compliance to applicable SOPs, regulations and applicable standards

- Oversee compliance auditing program to fulfil regulatory requirements

- Provide expertise and guidance to organizations departments in interpreting and implementing governmental and guidelines to assure compliance

- Follow applicable regulations, including organizations policies and procedures

- Provide Quality Assurance input to organizations strategic goals in form of schedules, quality plans, and budgets

- On the technical side oversee, prepare and conduct trainer technical training programs for oncology data management

- Assess training needs and certification requirements

- Help create instructor materials (course outlines, background material, instructional materials, and training aids)

- Deploy training to targeted personnel

- Prepare training material and classroom agenda

- Conduct presentations and webinars

- Assist in design of computer-based and multimedia curriculum

- Continuously enhance technical instructional delivery and presentation skills

- Mentor other instructors in the subject matter, content, and course delivery techniques for assigned technical courses

- Ensure the quality and consistency of course content throughout a course life cycle.

- Test process with different subjects

- Manage the training program in accordance with business needs, regulatory requirements, and Quality standards

- Plan and direct classroom training, electronic learning, multimedia programs, and other computer-aided instructional technologies, simulators, conferences and workshops

- Review existing material for accuracy and provide guidance on the updating of those materials

- Client facing to understand project requirements to develop necessary training materials

- Query resolution related to medical, clinical, oncology. Ability to identify questions that require escalation to client and facilitate discussions with the client (medical team, Sr. medical directors, oncologists, PIs)

Education and Experience:

- 10+ years of relevant and current work experience in QA in Clinical Research / Clinical Data Management, KPO, Healthcare or Hospitals industry

- Must have exposure in US Healthcare

- Experience in handling oncology related projects / teams

- Familiarity with the methods and principles for designing oncology training programs

- Six Sigma black belt / Master black belt certification

- Ability to lead a team is necessary, should have led large teams in past

- Demonstrated management experience with evidence of being an impactful, influential, and involved leader and mentor

Required Skills / Abilities:

- Excellent communication skills and abilities to collaborate with and present to individuals of varying levels of authority, including senior and Executive leadership

- Strong organizational and time management skills

- Attention to detail with an ability to perform critical review of various types of documents

- Outstanding written and verbal skills

- Ability to independently solve problems and work cross-culturally

- Demonstrated ability to work as a team player with multi-disciplinary project teams