Investigator Jobs in Bengaluru

Investigator Payments Analyst Location: Bengaluru Job Overview: The Investigator Payments Analyst is responsible for supporting the delivery of all required start-up contracting activities for selected sponsors, studies, or multi-protocol programs. This includes pre-award activities and providing essential operational and financial contracting support. The role ensures compliance with sponsor requirements, regulatory guidelines, and project timelines. Essential Functions: Grant Estimates & Proposal Support: Develop simple investigator grant estimates and proposal text to support the proposal development process. Contracting Tools & Systems: Utilize and maintain contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors, ensuring alignment with the Scope of Work and Project Plan. Collaboration & Communication: Coordinate with sponsors, stakeholders, and RSU regions to ensure successful delivery of projects in compliance with sponsor requirements and the RSU Management Plan. Operational & Financial Support: Provide operational and financial contracting support to facilitate business development and efficient initiation and maintenance of clinical trials, ensuring compliance with regulatory requirements. Documentation Support: Assist in creating and reviewing scientific, technical, and administrative documentation to support business development and enable study initiation and maintenance. Contracting Intelligence: Contribute to the collection, interpretation, analysis, and dissemination of contracting intelligence for assigned studies and the company. Efficiency & Reporting: Ensure contracting efficiency and adherence to project timelines and financial goals, and report on performance metrics and out-of-scope activities. Compliance & Quality Standards: Ensure compliance with contract management and quality standards, providing administrative and operational support to investigators and managers as required. System & Database Management: Accurately complete and maintain internal systems (including CTMS), databases, tracking tools, timelines, and project plans. Qualifications: Education: Bachelor's degree required. Experience: At least 1 year of relevant experience, including demonstrable experience as a contract negotiator or equivalent combination of education, training, and experience. Skills & Knowledge: Negotiation & Communication: Strong negotiation and communication skills to facilitate contract discussions and maintain professional relationships with sponsors. Interpersonal Skills: Ability to work effectively in teams and with internal and external stakeholders. Technical Writing: Strong technical writing skills for creating and reviewing proposals and documentation. Clinical Trial Knowledge: Understanding of clinical trial environments and the drug development process. Regulatory Knowledge: Knowledge of GCP/ICH guidelines, applicable regulatory requirements, and SOPs. Organizational Skills: Excellent organizational and planning skills for managing contracting activities. Software Proficiency: Strong knowledge of Microsoft Office and other relevant software tools. Contract Management: Good understanding of clinical trial contract management, including pricing models, proposals, and budgets. Additional Skills: Ability to interpret pricing models, prepare proposals, bid grids, and budgets. Ability to work in a matrix team environment and build effective working relationships with sponsors, co-workers, and managers. Ability to exercise independent judgment when negotiating contracts and making decisions. This role offers an exciting opportunity for individuals who have a strong foundation in contract negotiation and management, along with an understanding of the clinical trial landscape. If you are a detail-oriented, proactive individual with a passion for working in the healthcare and clinical trial industries, we encourage you to apply. Qualification : Bachelor's degree required.

Work Schedule Other Environmental Conditions Office Job Description Coordinates, oversees and completes functions on assigned trial activities detailed on the task matrix. Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. Follows up for resolution of findings and raises whenever vital. Ensures allocated tasks are performed on time, within budget and to a high quality standard. Bring ups in cases of variances (overburn/underburn) for self and junior PSCs, reviews and re-distributes the tasks based on junior PSC s free capacity Supports the maintenance and oversight of study specific documentation and global support with specific systems, tools and trackers to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. P ro v i de s s y s te m ( i. e . C T M S , O r a c le A c t i v at e & e T MF) s u pp ort b y m a n ag ing t he a cc e ss r eq u e s t s, supervising s t u d y l e v e l d o c u me n t s, ma i n t a ining a u d it r ead in e s s a nd presenting t he n o n - c o mp li a n c e t o t he s t u d y tea m and suggesting resolution . Pe r f or m s adm inis t r at i v e ta s k s on a ssi g n e d t ri a ls i n c l u d i n g , b ut not li m i te d t o: t i me ly p ro c e ss i ng o f d o c u m e n t s s e nt t o CR G ' s /C li e nt e T MF as required, pe r f or m ing C R G ' s /C li e nt e T MF r e v i ew s a nd c oo r d in at i n g and proposing is s ue r e so l u t io n , pe r f or m ing ma s s ma ilin g s a nd c o m m un i c at ions a s n e e ded , p ro v i d i ng d o c u me n t s a nd r ep or t s t o in te r n a l tea m membe rs. Su pp or t s s c h ed ul i ng a nd o r ga niz at ion o f c li e nt a nd / or i n te rn a l meet in g s w i t h c o mp l et ion a nd d is t ri b u t i on of r e l ate d meet ing m i n u te s and follow up for closure of action items, if required. E x p or t s a nd r e c o n c il e s s t u d y met ri c s r ep or t s, and if required analyzes and identifies issues (if involved in a Lead role . Maintains and regularly checks for correctness of vendor trackers. Drives and coordinates the compilation of Investigator Site File (ISF) template, pharmacy binder with instruction from the Clinical Team Manager. Attends Kick off and Project Launch meetings and takes notes when required, supports initial study set-up. Ed u c at ion a nd E x pe ri e n c e : Hi g h / S e c on da r y s c hool d i p lo m a/ eq ui v a l e nt a nd r e l e v a nt f or ma l a c adem i c / v o c at ion a l q u a l i f i c at ion T e c hni c a l p osi t io n s ma y r e q uire a c e r t i f i c at e P r e v ious e x pe ri e n c e t h a t p ro v i de s t he k no w l edge , s k il l s , a nd ab ili t i e s t o pe r f o rm t h e j ob ( c o mpa r ab le t o a t l ea st 0 to 4 y ea rs ) . Qualification : High / Secondary school diploma/ equivalent and relevant formal academic / vocational qualification

In this role the position will be based in India however will be working with teams in Japan and supporting the delivery of work in country. This would involve direct liaison with project teams, investigative sites and sponsors as might be required. All the communications would be expected to be done in Japanese and English- both written and verbal. Job Purpose: The role of the Clinical Operations Assistant (COA) is to maintain the paper and electronic Central Files for Clinical Operation, ensuring efficiency, accuracy and quality. Depending on the location of the role may include the tracking, scanning, filing, entry and return of Case. Report Forms to clients for assigned projects, upload and naming of documents to the electronic document management system, EDC User Management activities and activities associated with Impact Harmony, as appropriate. COA is also to support all site management team members on local billable administrative tasks and assist with QC of Central files. Key Accountabilities: Track, scan, code, and apply naming convention and send documents to the relevant study Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan. Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP) Photocopy, print distribute and retrieval of documents, as needed Maintain basic quality check procedures to ensure accurate maintenance of documents Tracking/maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers (Client additional request only) Monitoring of the status of systems and processes (e.g. annual reporting obligations, Site Compliance regarding Safety Information System (SIS) etc.) to ensure compliance Organization of translations of study document (e.g. contacting translation company, requesting approval via Oracle, following up with translation company to ensure timely delivery) Payment/invoice processing including internal follow up with payment specialists in Finance Courier shipment of study document to the sites, vender and clients Collection of internal signatures for site documents (e.g. confidentiality agreement or clinical site agreements) within PAREXEL Skills: N2, N3 fluency in Japanese (reading, writing, and speaking) Sound problem solving skills. Experience working in CROs or Life Sciences industry preferred. Support with document collection, customization, review for clinical trials being conducted in Japan. Liaise with sites & investigators on assigned projects to facilitate conduct and delivery. Work closely with project management teams on all assigned tasks. Ensure quality and compliance in all clinical research activities. Ability to interact professionally within a client organization. Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise. Strong interpersonal, verbal, and written communication skills. Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables. Effective time management in order to meet study needs, team objectives, and department goals. Knowledge and Experience: Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology Education: Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience N2, N3 fluency in Japanese (reading, writing, and speaking) Qualification : Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience