Shyam Panhale

• Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity and work as regional Clinical Team Lead
  
  Essential Functions:
• Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.
• Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
• Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
• May coordinate all start-up activities and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines.
• Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

· Trains & mentors CTLs, CRAs and IHCRAs in multiple areas of expertise.

· Presenting during BID defense meeting including preparation of materials. Presenting etc.

· Responsible and accountable for the management of the Clinical Operations team with particular emphasis on teamwork, quality, timelines, budget, metrics and compliance with the project plans and SOPs.

· To serve as Primary liaison and primary point of escalation for clinical activities and team issues, interactive with clients, vendors and other Covance functional areas.

· To lead Team of CRAs, IH-CRA, CPA and Start-up Operation team.

· To collaborate with Project management to build and foster the client relationship and provide data for clinical performance metrics and project status metrics applying and drawing conclusion between project activities/deliverables and project metrics and initiating measures to project metrics.

· Develop the strategy, plans, tools and training to oversee and assess performance of the clinical team, in the conduct and compliance of site visits (on site and remote), including, but not limited to: pre-study visits, site initiation visits, routine monitoring visit, motivational visits, close-out visits, audit support visits.

· Proactively communicate with CRAs and other members of the clinical operations team to follow up on all open issues, drive patient recruitment and retention, in order to meet the project timelines.

· Ensure that all study related, clinical related documents are tracked, filed and reviewed (QC check) and complete according to the SOPs, regulatory requirements and protocol.

· Responsible and accountable for understanding and managing the clinical operations budget for the project, and ensure that the activities are within budget and scope of work, and to discuss with the project team to support financial progress, and team utilization.

· Communicate effectively with all members of the project team and client as applicable, to support the study completion per company and client requirements and timelines, including risk identification and mitigation, issue escalation and working with Quality and the project team on Corrective and Preventative Actions.

· As required by the project roles participate and oversee the site selection process; depending on the scope and roles within the project team, this may be performed in collaboration with other team members

· As required by the project roles participate and oversee the regulatory/ethics committee submissions, tracking and documentation.

· Support new business with active participation in bid defence preparation and meetings, as required

· Perform other duties as required by the department or project team.

· Prepare, Present and support during DCGI meeting for India related studies.

· Review and Approve payment realted to IRB/Site and Subject payment

• Ensure accurate and timely trip report completion and trip report review and the quality of reports are of the highest standards, errors are minimized and that issues are escalated as appropriate.
• Follow project issue escalation process and Covance Corrective Action Issue Resolution (CAIR) process for clinical operations issues.
• Ensure site monitoring responsibility for clinical studies are conducted according to Covance.
• Standard Operating Procedures, ICH Guidelines and GCP.
• Ensure follow up on action items and protocol deviations and to be a liaison between CRA, CTL and PM for timely resolution of issues.
• Responsible for the timely and appropriate communication to the clinical operations team.
• Liaise with CTL/PM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety.
• Assures the implementation of project plans as assigned.
• Assist with training, mentoring, and development of new employees.
• Review progress of project and initiate appropriate actions to achieve target objectives.
• Contribute to improvements to enhance the efficiency and quality of work on assigned projects

· requirements.

· Manages the set up and maintenance of electronic Trial Master Files (eTMF), (Trial, Country and Site artifacts) for clinical studies in accordance with TMF processes, working with key study personnel such as the Project Manager.

· Leads the development, creates and maintains of the eTMF Plan and TMF Index with Project Manager/Study Lead and/or sponsors.

· Responsible for mapping the sponsors TMF Index, if applicable, to the Covance TMF Index and adds/modifies all approved TMF artifacts in the Covance TMF Index, according to Covance SOP’s, and/or sponsor SOP’s

· Maintains the TMF in a state of audit readiness for quality and compliance by: 1. Visual quality checks of e-documents prior to release to confirm image clarity and readability. 2. Performing Audit Ready Checks on individual documents uploaded in the eTMF system for every study, ensuring context is accurate; 3. Initiating the What’s Missing for all documents and ensuring full completeness of the TMF for each study, tracking and obtaining missing, incomplete, incorrect, inaccurate artifacts against the TMF Plan and study milestones. • Comply with metrics established for performance TMF reviews.

· Process and track final essential artifacts required throughout all phases of the study in accordance with Covance SOPs, sponsor SOPs, GCP and ICH guidelines. • Manages the identification of operational and logistical issues and resolutions related to the TMF. • Responsible for gathering data requested by study team to support status reports to clients.

· Prepares the TMF for QA or Sponsor audits, leads the resolution with identifying and implementing corrective actions to findings in audit reports.

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
• General On-Site Monitoring Responsibilities (a) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• (b) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• (c) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
• Monitor data for missing or implausible data
• (d) Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy
• (e) Prepare accurate and timely trip reports
• Responsible for all aspects of site management as prescribed in the project plans
• Responsible for all aspects of registry management as prescribed in the project plans
• Undertake feasibility work when requested
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
• Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
• Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
• Assist with training, mentoring, and development of new employees, e.g
• Co-monitoring
• Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
• Perform other duties as assigned by management.

• CRA ( Lead CRA) and CQC Assessor for India and Srilanka)
• Team Lead for Global Phase III Cardio Vascular Outcome study for APAC region (Singapore, Malaysia, Taiwan Philippines, Thailand, Sri Lanka, South Korea, India and Hong Kong )
• Serve as lead monitor for a protocol or project and assist in establishing/developing project related plans as assigned
• Review progress of projects and initiate appropriate actions to achieve target objectives
• Organize and make presentations at Investigator meetings
• Interact with internal work groups to evaluate needs, resources and timelines
• Responsible for all aspects of registry management as prescribed in the project plans
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study related documents, organisation of meetings and other tasks as instructed by supervisor as assigned
• Negotiate study budgets with potential investigators and assist Covance legal department with statements of agreements as assigned
• Complete process of Serious adverse event (SAE) reporting, process production of reports, narratives and follow-up of SAEs
• Assist with training, mentoring and development of new employees, eg co-monitoring
• Co-ordinate designated clinical projects as a local project coordinator (with supervision if applicable) and may act as local client contact as assigned
• Perform other duties as assigned by management
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation of visits; liaise with vendors; and other duties as assigned
• Responsible for all aspects of site management as prescribed in the project plans
• Conduct and Perform QA review of the project with the QA team member once in a month
• Conduct audits
• Reporting following to the management: WSR (Weekly status reports and trackers) Bi-weekly dashboard
• Hosting APAC Biweekly CRA calls
• Trip Report Reviewer for APAC and EU Region, Sr
• CRA (Lead CRA) CQC Assessor -APAC Region - India, Singapore, Malaysia, Taiwan, Philippines, Indonesia and Vietnam )
• Lead CRA for Global Phase III Schizophrenia study for AP region (Philippines’, Taiwan and Malaysia)
• Lead CRA for Global Phase III Dyslipidemia study for AP region (Philippines and India)
• Responsible for leading the clinical team in a given project(s) and ensuring quality of the project by adherence to good clinical practices, compliance with the protocol and all project procedures, and with the agreed SOPs
• Responsible for planning and tracking the conduct of the study in compliance with the study budget, the quality standards and timelines
• Responsible for identification and resolution of project-specific clinical operations issues and problems in consultation with the Project Manager (global/ regional), with an awareness of the project budget, timelines and quality standards
• To co-ordinate with different service providers within a project (all centralized services, Data management, couriers, another CRO, local affiliate of sponsor) To update the Sponsor/ internal customer about the study progress at a pre-defined periodicity
• To identify, evaluate and suggest resolutions in a timely manner for project risks
• To conduct periodic study team meetings, teleconferences with the team members and/or Investigators and to ensure that minutes/ action items are appropriately documented and circulated
• Assist with providing ongoing training and support to the clinical team for the appropriate conduct of the study
• To make, implement and execute the clinical management plan for the study
• Conducted Quality check visit as CQC Assessor in countries like Singapore, Malaysia etc
• Conducted new CRAs assessment onsite in Singapore and Malaysia as per Covance standard SOP to meet Monitoring skills of new CRAs
• Mentoring of New CRAs who Joined in Covance Singapore
• Hosting APAC Biweekly CRA calls
• Responsible for Trip Report Review for APAC regions
• Designation- SR
• CRA and Start Up Lead for Asia P pacific Region
• Administration and monitoring of clinical research projects according to Covance Standard Operating Procedures and ICH -GCP Guidelines
• Manage small projects under direction of a Project Manager / Director as assigned
• Monitored and site management of 2 sites in India for a Global Phase III Schizophrenia study
• Monitored and site management of 3 sites in India for a Global Phase III Primary Hypercholesterolemia or Mixed Dyslipidemia study.
• Activities like preparation of country specific ICF, ICF Finalization, & CTA finalization and budget negotatoion with the sites
• Involved in budgeting of clinical trials and third party vendor management, managing logistics and coordinating with various department to ensure that study timelines are met and high quality data is generated and also to tack study finance on monthly basis
• Managing GSS Lead activity of AP region (Philippines’, Taiwan and Malaysia) and GSS specialist from respective countries are reporting to me about start up activity including Regulatory submission, ICF development, collecting of essential documents from the site, EC submission, and approval CTA finalization and budget negotiation , submitting of documents for IP release, scheduled of SIVs
• Mentoring to GSS ( Global Site service ) staff for sit start up activity and Conduct Frequent team meetings and ensure regular communication with GSS staff
• Team Lead for Dyslipidemia study where 5 CRAs from India and 2 CRAs from Phillipines reporting to me
• Responsible for Trip Report review and approval for India and Philippines
• Identify quality issues within the study through regular review of the clinical team communications including site communications, monitoring visit reports, data flow information and quality assurance audit findings
• Conduct accompanied monitoring visits at for protocols that are complex and/or require knowledge in advanced therapeutic areas
• Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements
• Conduct Frequent team meetings and ensure regular communication with India and Philippines CRA
• Ensure high performance and efficiency of the clinical team through co-monitoring/accompanied site visits and ongoing mentoring of CRA team

• Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer
• Interprets data on complex issues and makes good business decisions with support from line management
• Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations
• Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team
• Typically works independently on projects of moderate to high complexity and work as regional Clinical Team Lead
• Essential Functions:
• Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP
• In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g
• Process improvements, manage complex programs, have wider management or project coordination responsibilities
• Develops clinical tools (e.g
• Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan
• Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents
• Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central)
• May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required
• Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings
• Collaborates with the clinical team and other departments as needed to meet deliverables of the project
• Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained
• Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies
• Responsible for the timely archiving of documents and study materials for the department
• Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution
• Continuously monitors clinical trials to assess performance and ensure contractual obligations are met
• May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials
• Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues
• May coordinate all start-up activities and ensures that essential document quality meets the expectation of Regulatory Compliance Review
• Ensures timely regulatory submissions (if appropriate) are addressed
• Reviews and follows up on all questions raised by ethics committees
• Responsibilities may vary based on project timelines
• Provides input into preparation of forecast estimates for clinical activities
• Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements
• Trains & mentors CTLs, CRAs and IHCRAs in multiple areas of expertise
• Presenting during BID defense meeting including preparation of materials
• Presenting etc.

• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• 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 clinical Team Lead (CTL) and/or line manager
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment case report form (CRF) completion and submission, and data query generation and resolution
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation
• May provide assistance to more less experienced clinical staff
• To mentor lesser experienced staff and provide support to the Project Manager as a Lead CRA

• Understand functionality of all digital devices available as per the latest technology implemented in the Digital Lab at QECG Services
• Retrieve ECGs and generate printouts in required formats
• Ensure that the database is updated and ECGs are filed into specific client folders for storage and easy retrieval
• Create regular information reports regarding the ECGs received and the status of the ongoing work
• Support the regular maintenance work on the digital systems with support from IT team and vendors
• Create and maintain documentation regarding the digital system installation, configuration and maintenance
• Perform on-site and telephonic training of ECG devices for site staff
• (4 years) in line management and mentoring a team of 4 cardiology technicians in Quintiles ECG Laboratory in order to meet their personal development, project and departmental needs