Sudhakar B Email & Phone Number

Bengaluru, Ka, In

Bengaluru, Karnataka, India

Lead a team of 20 people involving local RSU, cRSU, local contract & budget from different countries.Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelinesDevelop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related… Show more Lead a team of 20 people involving local RSU, cRSU, local contract & budget from different countries.Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelinesDevelop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where requiredEnsure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management PlanCreate and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as requiredProvide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirementsProvide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizationsIdentify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation planAssess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as requiredExecute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Show less

Bengaluru, Karnataka, India

• Lead a team of 25 people involving local RSU, cRSU, local contract & budget from different countries.• Participation in Sales preparation and attendance at client meetings and BD defense • Participates in executing Global/Regional SSU initiatives • Understand client objectives and assist in the development of the plan for country and site distribution • Understand client objectives and be accountable for the development, implementation and execution of the Study Start Up… Show more • Lead a team of 25 people involving local RSU, cRSU, local contract & budget from different countries.• Participation in Sales preparation and attendance at client meetings and BD defense • Participates in executing Global/Regional SSU initiatives • Understand client objectives and assist in the development of the plan for country and site distribution • Understand client objectives and be accountable for the development, implementation and execution of the Study Start Up Strategy from site identification (PSV) to SIV in all countries across assigned region.• Serve as the primary contact with the Sponsor, PM other Function Leads and Third Parties who have an impact on Study Start Up. Work with key stakeholders to optimize performance and collaborate to ensure successful study outcomes.• Responsible for all Study Start Up activities in accordance with agreed budgeted hours, manage and escalate any significant variation to study budgets.• Responsible for the provision of Study Start Up metrics for assigned studies.• Attend study related meetings and calls for all assigned studies• Deputize for the Study Start Up Manager/Designee when assigned Show less

Bengaluru Area, India

· Lead a team of 25 people involving 14 Central Monitors, 8 CMA and 3 Centralized Monitoring Leads.· Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines ·… Show more · Lead a team of 25 people involving 14 Central Monitors, 8 CMA and 3 Centralized Monitoring Leads.· Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines · Establish and maintain effective project/ site communications · Create and maintain relevant project documents/ trackers · Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information · Review, evaluate and recommend modifications to designated processes· Oversee and participate in document management (creation, review, maintenance, storage, as applicable)· Participate in (study) team meetings and implement action items· Collaborate with the project lead/team members in creation/review of study documents including Quality manuals· Act as point of contact for assigned deliverables for specific customers or projects· Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.· Escalate quality issues to relevant stakeholders and/or line manager. Show less

Pune Area, India

➢ Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.➢ Selection and onboarding process for new staff by conducting candidate review and conducting technical interview process.➢ Conduct on-boarding training for new staff and mentor… Show more ➢ Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.➢ Selection and onboarding process for new staff by conducting candidate review and conducting technical interview process.➢ Conduct on-boarding training for new staff and mentor staff assigned to them.➢ Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.➢ Participate in the allocation of resources to projects by ensuring assignments are appropriate to staff experience and training➢ Act as a primary liaison between the Sponsor and the PI to ensure study conduct, and close-out according to applicable regulatory guidelines.➢ Independently handling and managing projects at end-to-end basis to ensure its completion in the scheduled time frame.➢ Site Feasibility/ Site Initiation/ Monitoring/ Site close-out. Show less

Goa, India

➢ Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.➢ Selection and on boarding process for new staff by conducting candidate review and conducting technical interview process.➢ Manage the effective transitions for staffs➢… Show more ➢ Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.➢ Selection and on boarding process for new staff by conducting candidate review and conducting technical interview process.➢ Manage the effective transitions for staffs➢ Manage feedback/escalation to monitor study deliverables and mitigate risk operationally➢ Participate in the allocation of resources to projects by ensuring assignments are appropriate to staff experience and training.➢ Main contact with sites, performed site visits from selection to close-out, evaluated and ensured patient safety, data quality, adherence to the protocol and agreed SOPs.➢ Complied with overall study timelines to maintain recruitment progress, data cleaning and appropriate IMP management. Show less

Mumbai Area, India

➢ Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.➢ Selection and on boarding process for new staff by conducting candidate review and conducting technical interview process.➢ Participate in the allocation of resources to projects… Show more ➢ Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.➢ Selection and on boarding process for new staff by conducting candidate review and conducting technical interview process.➢ Participate in the allocation of resources to projects by ensuring assignments are appropriate to staff experience and training➢ Manage the effective transitions for staffs➢ Manage feedback/escalation to monitor study deliverables and mitigate risk operationally Show less

Chennai, Tamil Nadu, India

➢ Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. ➢ Site initiation, Site monitoring, Site close out.➢ Overall incharge to conduct the study

Hyderabad, Telangana, India

Study initiation, study monitoring, study closeout.

Chennai Area, India

$ Improving the market strategies.

M.Pharmacy, Pharmacology, 1St

Master Of Business Administration (Mba), Project Management, 1St

Bachelor Of Pharmacy (B.Pharm.), Pharmacy, 1 St

Hsc,Sslc, School