Line Management of Regional Site Activation Managers /Reg & Start up Leads & Asia Pac Regional Site ID oversight

Line Management of Regional Regulatory & Start up Leads in the Asia Pacific region.

Line Management of Regional Regulatory and Start up Leads in the Asia Pac region.

Manage projects as Regulatory and Start lead for Asia Pac region (Asia and ANZ)

Manage projects as Regulatory and Start lead for Asia Pac region (Asia and ANZ)

• Serve as Site Start-Up lead within a country or region for projects or service line. Lead SSU team or service line members in all designated activities. Monitor team efficiency and adherence to project timelines. • Ensure adherence to standard operating procedures (SOPs) and work instructions (WIs) and quality of designated deliverables.• Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.• Review and provide feedback to management on site performance metrics.• Work with sponsors and internal team members to establish regulatory requirements and contracts necessary for startup.Review and negotiate regulatory documents, contracts, and contract amendments with sites and sponsors foragreement on wording and budgets. Ensure accuracy and completeness of documents.• Serve as central contact for investigative sites, designated project reports, and customer service.• Resolve site issues and determine status for product shipment.• Work with regulatory team members or sponsor to secure authorization of regulatory documents.• Work with legal team members or sponsor to secure authorization of contracts.• Work with Clinical Operations, Project Management and Site Identification on SSU project specific status anddeliverables.• Where applicable, provide work instructions to team members in preparation of regulatory submissions.• May translate or review completed translations of critical documents.• May participate in feasibility and/or site identification activities.

-Work with sponsors and internal team members to establish regulatory requirements and contracts necessary for SSU• Where applicable, review and ensure project work instructions for SSU projects are completed and accurate.• Resource staff efficiently to ensure achievement of utilization and SSU realization targets.• Interact with Clinical Operations, Project Management and Site Identification on SSU project specific status anddeliverables.• Review and analyze site performance metrics and processes to provide input in the development and implementation of process/system improvements.• Accountable for staff efficiency and adherence to standard operating procedures (SOPs), work instructions, and projectinstructions and timelines.• Identify and make recommendations to resolve ongoing training and development needs of staff.• Manage staff in accordance with organization’s policies and applicable laws. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions for all management / human resource matters.• Mentor SSU Specialists and ensure adherence to start-up project timelines, scope of work and budget.• Serve as SSU Lead for single projects or programs as necessary.

Taking care of all the activities from site identification to site initiation and preparing the site for Initiation.

Conducting feasibilities for non-win studies, preparing feasibility reports, maintaining a database of soft copies of the feedbacks sent to the BD, Identifying new sites.

1. Site Selection2. Study initiation3. Study Monitoring:On-Site Monitoring & In-house Monitoring4. Study Termination5. Performs administrative duties including attendance at clinical monitoring staff meetings, project team meetings, clinical committees, clinical training sessions, etc.6. Identifies and records quality problems. Suggests, initiates, recommends and/or provides solutions as appropriate.7. Attends refresher-training sessions, as directed.8. Maintains awareness of overall developments in the field of clinical research, as well as assigned areas, by reading related literature, attending professional meetings, etc.9. Performs other study related tasks as assigned by supervisor.

• Project Management:1. Assist with Study protocol design, development, and / or review.2. Development of study-specific handbooks / guidelines / documents.3. Laboratory / specimen handling procedures.4. Drug formulation and administration procedures.5. Drug formulation and administration documentation records.6. Source documents / worksheets.7. CRF preparation, review and editing.8. Informed consent form development and review.9. Interaction with other clinical operations staff to co-ordinate study preparation; ensure adequacy of supplies for each study.• Project – Specific Duties:1. Regular communication with Medical Monitor, Clinical Operations staff, PI, and study personnel.2. Perform pre-study, initiation, interim monitoring and close out visits; report preparation after.3. Ongoing monitoring of sites which includes source data verification, observance of protocol adherence, assessment of CRF entries.4. Interaction with other clinical operations staff to oversee the co-ordination of study preparation; ensure adequacy of supplies for each study.5. Co-ordinate development of site / monitoring manuals.6. Ensure adequacy of drug shipment and drug accountability.7. Site management; ensure proper adherence to the study protocol, "troubleshoot" any problems that might arise during the study.8. Monitoring of clinical trials; to ensure adherence to good clinical practice in accordance with ICH, Declaration of Helsinki, Federal regulatory requirements; compliance with all study procedures.

Copy-Edit articles to be published in Scientific Journals according to the requirements put forth by the different Journals.

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