1120 Clinical Research Jobs - Page 7

Brief Position Description: The Investigator Grant Specialist is responsible for the development of Investigator grant, supporting the various groups related to use of industry systems such as Grant Plan. The Investigator Grant Specialist will work closely with Project Management and Clinical Operations to ensure timely delivery of site budget templates. The ideal candidate will be professional, analytical and possess excellent written and verbal communication skills. Minimum Qualifications & Experience: Bachelor s Degree in a relevant field (science or other) or professional certification. Experience in Clinical Trial industry. Knowledge regarding industry standard benchmarks, fair market value and proven expertise using investigator grant software (e.g. GrantPlan). Experience in reviewing and understanding study protocols, study budgets, as well as other technical, medical and legal documents related to investigator grants. Excellent communication and organisational skills. Business acumen. Attention to detail. Strong planning and problem-solving skills. Computer expertise with document and spreadsheet applications. Responsibilities: Responsible for the development of investigator grant using industry standard systems. Review study protocols work closely with Project Managers to ensure accurate, complete and timely deliveries of Investigator Grants. Provide initial budget estimates as requested by clients Apply Industry standard of care concepts into building budget model. Address questions related to Fair Market Value. Communicate with vendor for system related issues. Manage list of user access to required systems. Track finalised budgets and ensure reporting as required. Provide training to groups as appropriate. Work proactively to implement process improvement that reduces cycle time. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: At least 12-36 months of experience in a clinical research organization or equivalent. Minimum Batchelor s degree in Life science or related field Experience working in Investigator Payment Process. Experience working in CTMS/Veeva. Experience working in Grant Plan. Understanding of Subject Visit Tracking in CTMS. Strong hold on excels and Power Point (MS). Effective communication skills. Must have analytical, problem solving, Excellent verbal and written communication and negotiation skills. Excellent interpersonal and relationship building skills. Extremely well organized and detailed oriented with demonstrated follow-up skills. Should have prior background in the pharmaceutical, CRO or healthcare industry. Responsibilities: Investigator Payment Activity To review, update and track all payments in CTMS appropriately. To route correspondence appropriately and ensure all queries raised have been assigned to the correct team member in a timely manner. To escalate payment issues/delays appropriately. To review payments in line with visit data in CTMS to ensure sites are being paid timely accurate and efficient manner and escalate delays/ issues appropriately. Communicate effectively with Project Managers, regarding payment enquiries and managing their expectations accordingly. To support Clinical staff in executing accurate, timely and efficient investigator payments in accordance with investigator contract. Assists with maintaining schedule for patient visit payments per contract with the Sponsor and the Site. Process all site payments for patient visits. Review the site payment report based on the required due date for payments to be made to make sure the report is correct and free of errors before processing any payments. Prepare Investigator Payment report for study status meetings as requested by Project Manager. Be accountable for the quality of how each study assigned is set-up and maintained, ensuring payments are correct and that all work conducted is in accordance with Investigator Payment processes and procedures and is audit Analyse and assess SVT setup requirement based onstudy type (simple/complex/cohort). Create site SVTs based on CTRAs received from CRAs. Setup Master/Site specific SVT templates in CTMS within the required timelines and ensure accurate templates are built in before release to study teams. Be aware of and adhere to company processes in areas relevant to Investigator Grant Specialist. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when conducting IGS role. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. Investigator Grants Activity Responsible for the development of investigator grant using industry standard systems. Review study protocols work closely with Project Managers to ensure accurate, complete, and timely deliveries of Investigator Grants. Candidate will be assigned in the complex projects. Provide initial budget estimates as requested by clients. Apply Industry standard of care concepts into building budget model. Address questions related to Fair Market Value. Communicate with vendor for system related issues. Manage list of user access to required systems. Track finalized budgets and ensured reporting as required.

Job Overview Support the continuous improvement of the staffing function through development and implementation for all staffing programs in an assigned business unit/department, primarily in one geography. With guidance, conduct recruiting activity for management teams as assigned. Essential Functions Work with management in assigned service areas, business units or departments to source, select and hire qualified candidates to fill vacant positions using cost-effective techniques and in accordance with company policies, procedures and processes. Write job postings to post and advertise positions. Review applications and conduct interviews to obtain information regarding applicants work history, education, training, job skills, and salary requirements. Create and coordinate job advertising in various media. Attend job fairs and develop and maintain contacts with colleges, universities, alumni groups, and other organizations to identify potential applicants. Work with external recruiters and employment agencies to identify and recruit candidates. Utilize Internet online recruiting sources to identify and recruit candidates. Meet with functional business leaders and executive management, as required, to discuss and establish staffing objectives and ensure they are achieved. Assist with training line management on recruiting, interviewing, and the selection process as required. Support a diverse workforce and comply with local and regional hiring guidelines and procedures, particularly for applicant tracking. Keep abreast of market trends and demands impacting the company s ability to attract competitive candidates; coordinate with the compensation team on salary offer considerations and equity concerns. Ensure the provision of timely employee-related information to management teams as necessary. May be responsible for meeting established financial targets and assisting with business development activities depending on business line. Qualifications Bachelors Degree Req 1 year experience within a staffing function as a recruiter or combination of recruiter and specialist experience Req Or Equivalent combination of education, training and experience Req Sound knowledge of legislation in the recruiting process Strong computer skills including Microsoft Office applications and HRIS applications Strong verbal and written communication skills Strong attention to detail Good problem-solving, judgment and decision-making skills Good understanding and awareness of the commercial environment and market trends Good customer service skills Very high degree discretion and confidentiality Ability to multi-task, prioritize and plan routine activities Ability to establish and maintain effective working relationships with coworkers, managers and clients . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Cundall is looking for Senior Public Health Engineer to join our dynamic team and embark on a rewarding career journey Implement and monitor public health programs and infrastructure projects Conduct risk assessments, support sanitation initiatives, promote health awarenes Collaborate with medical teams and local authorities for health-focused engineering tasks

About the role: The Senior Finance Specialist is responsible for managing employee expense claims, ensuring compliance with company policies, and administering the corporate card program. This role requires attention to detail, a strong understanding of financial controls, and excellent customer service skills to support employees with their claims and card-related queries. Minimum Qualifications & Experience: Bachelor s degree in accounting, Finance, Business Administration, or a related field. 6+ years of experience in expense claims processing, accounts payable, or corporate card administration. Proficiency in Concur and Certinia system, MS Excel, and financial reporting tools. Strong attention to detail, problem-solving abilities, and excellent communication skills. Familiarity with corporate expense policies, tax implications, and financial compliance. Experience working in a shared services or multinational environment. Prior experience with corporate card programs and expense management tools. Ability to handle confidential information with integrity and discretion. Responsibilities: Expense Claims Processing: Review and process employee expense claims in accordance with company policies and guidelines. Ensure receipts and supporting documents comply with company policies and requirements. Verify approvals and escalate non-compliant claims to management. Coordinate with employees to resolve discrepancies or missing documentation. Process reimbursements through the Certinia system and liaise with Accounts Payable for timely payments. Assist in monthly expense accruals and reporting. Support Concur Technical team lead for new entity roll out and system enhancement initiatives. Stay updated on new Concur enhancements, features, and industry best practices, and proactively implement improvements to the system Manage helpdesk tickets, resolve user issues, and escalate problems as needed to ensure timely resolution. Corporate Card Administration: Manage the issuance, renewal, and cancellation of corporate credit cards. Maintain corporate cardholder records and ensure adherence to company policies. Monitor transactions for policy violations and follow up with employees as needed. Reconcile corporate card statements and ensure timely settlements. Support employees with card-related inquiries, including lost/stolen card replacements. Collaborate with the bank or card provider for troubleshooting and program enhancements. Compliance & Reporting: Ensure compliance with company policies, tax regulations, and audit requirements. Generate and analyse expense reports to identify trends, policy violations, and cost-saving opportunities. Assist in audits by providing required documentation and explanations. Recommend process improvements to enhance efficiency and reduce errors. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: Bachelor s degree in accounting, Finance, Business Administration, or a related field. 6+ years of experience in expense claims processing, accounts payable, or corporate card administration. Proficiency in Concur and Certinia system, MS Excel, and financial reporting tools. Strong attention to detail, problem-solving abilities, and excellent communication skills. Familiarity with corporate expense policies, tax implications, and financial compliance. Experience working in a shared services or multinational environment. Prior experience with corporate card programs and expense management tools. Ability to handle confidential information with integrity and discretion. Expense Claims Processing: Review and process employee expense claims in accordance with company policies and guidelines. Ensure receipts and supporting documents comply with company policies and requirements. Verify approvals and escalate non-compliant claims to management. Coordinate with employees to resolve discrepancies or missing documentation. Process reimbursements through the Certinia system and liaise with Accounts Payable for timely payments. Assist in monthly expense accruals and reporting. Support Concur Technical team lead for new entity roll out and system enhancement initiatives. Stay updated on new Concur enhancements, features, and industry best practices, and proactively implement improvements to the system Manage helpdesk tickets, resolve user issues, and escalate problems as needed to ensure timely resolution. Corporate Card Administration: Manage the issuance, renewal, and cancellation of corporate credit cards. Maintain corporate cardholder records and ensure adherence to company policies. Monitor transactions for policy violations and follow up with employees as needed. Reconcile corporate card statements and ensure timely settlements. Support employees with card-related inquiries, including lost/stolen card replacements. Collaborate with the bank or card provider for troubleshooting and program enhancements. Compliance & Reporting: Ensure compliance with company policies, tax regulations, and audit requirements. Generate and analyse expense reports to identify trends, policy violations, and cost-saving opportunities. Assist in audits by providing required documentation and explanations. Recommend process improvements to enhance efficiency and reduce errors.

Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About the team Oil & Gas This team is directly responsible for growth of Oil and Gas offline transactions & users at Paytm. About the role Team Leader To work with the business to understand and manage Programs being run for the Clients/Brands. And for accelerating the core growth metrics focusing on sales & distribution. Provides guidance and instruction to a working group about a project or portfolio of projects. These leaders are responsible for monitoring the efforts of the team members and getting the work done effectively and efficiently with the proper utilization of resources. Skills that will help you succeed in this role: 2+ yrs. of experience in Distribution sales in fintech, Banking/ Sales, EDC Sales. Develop plans and strategies for developing business and achieving the company's sales goals. Create a culture of success and ongoing business and goal achievement. Manage the sales teams and resources to deliver growth. Hire and build a new team to support our growing needs and future projects. Define optimal sales force structure. Define and coordinate sales training programs that enable staff to achieve their potential and support company sales objectives. Manage customer expectations and contribute to a high level of customer satisfaction. Define sales processes that drive desired sales outcomes and identify improvements. Going to the Merchant and educating him/her about the benefits of the Swipe machine (EDC) converting them and managing their accounts. Exceptional communication, presentation skills and relationship building skills. Ability to aggressively manage the successful execution of a sales strategy. Ability to work independently and collaboratively in a team environment. Qualifications: Bachelor's degree in business, marketing, or a related field (MBA preferred). Should have a strong understanding of the local language. Self-motivated and goal-oriented, with a demonstrated ability to work independently and as part of a team. Willingness to travel as needed to meet with clients and attend industry events.

Role & responsibilities Identifying/selecting an investigator who will be Responsible for The conduct of The trial at The trial site. Liaise with doctors/consultants or investigators on conducting the trial. Setting up The trial sites, which includes ensuring each centre has The trial materials, including The trial drug often known as The investigational medicinal product. Training The study staff in standard operating procedure for The clinical trials as per applicable regulatory requirements. Verify that investigator and investigators team are adequately trained and comply with The protocol. Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements. Monitoring The trial throughout specified duration involving Monitoring visit to The trial sites. Source data verification Informed consent form review, case report form review, investigational drug accountability, and adverse event review. Ensuring all unused trial supplies are accounted for. Writing visit reports, filing and collecting trial documentation and reports. Preferred candidate profile Pre-requisites for - Sr. Project Executive / CRA / Sr. CRA: B. Pharm/ BSc / Biotech + Clinical Research Degree / Diploma / Masters Candidate must possess excellent communication skills and ability to build excellent relationships with the trial staff and colleagues. ICH-GCP knowledge is a must. Ready to travel within and out of Mumbai at various trial sites. Willing to travel 50-60%. Attention to detail Good organisational and administrative skills (knowledge of word and Excel) Perks and benefits Salient Features of this job Chance to work in a supportive and flexible environment. Directly interact with customers from the USA and Europe. Vedic Lifesciences has been rated highly by our alumni last 22 years, as a great place to work and learn

Job description : Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues Act as a technical lead of the medical writing teams across projects and provide guidance and expertise for developing high-quality scientific content as required for various safety deliverables Establish good client communication and coordination within writing teams to manage stakeholder expectations and resolve any issues surrounding project/report deliverables Contribute to scientific publications and represent the company at scientific meetings and conferences Work with the project management team to implement quality and process improvement initiatives Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time. Summary of Responsibilities: Write and review various safety reports for global regulatory submissions for clients, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Clinical Overviews, Medical Device reports, and other documents as assigned. Lead the end-to-end process of report production and ensure the required quality standards and key timelines are met. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions. Act as the primary point of contact for the client for all report management activities. Engage in client communication to manage stakeholder expectations, present anticipated challenges, propose remediation, and escalate unresolved issues impacting deliverables at an individual report or project level. Author/review RMPs, ad hoc reports, Benefit-Risk Evaluation reports, supporting documents for label updates, reports of effectiveness of risk minimization measures or enhanced pharmacovigilance activities. Lead/participate in various steps of the signal management process. Provide inputs for developing signal strategies and retrieval of data from safety databases, scientific literature, and other sources, as required. Author/review signal evaluation/management reports (ad hoc and periodic) and safety issue analysis reports. Participate in safety/benefit-risk review meetings with clients, discuss results and conclusions from signal/safety analysis, and in collaboration with the safety physician, propose label updates and other risk mitigation measures, as needed. Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross functional stakeholders in the management and tracking of such feedback. Develop abstracts, posters, manuscripts, and other documents for scientific publication or presentation at conferences or pharmacovigilance forums. Prepare medical information responses for HCPs. Act as a writing coach, provide regular quality feedback, conduct training, and share best practices with associates for promoting the use of clear and concise writing and adherence to style guides, as applicable. Support project management activities such as maintenance of project schedules and tracking of metrics and compliance. Contribute to business development activities, including estimation of resource requirement and responding to RFPs. Create and update labels, e.g. Core Data Sheets, USPI, centralized SPC s, Med Guides. Conduct literature reviews, formulate and execute search strategies, including those for complex topics or research questions. Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables. Ensure compliance of operations with governing regulatory requirements. Create, maintain, and assume accountability for a culture of high customer service. Perform any additional activities per project requirement or at the manager s discretion upon completion of relevant training. And all other duties as needed or assigned. Qualifications (Minimum Required): Minimum of first degree in life sciences (or equivalent). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): At least 5-7 years of experience in the pharmaceutical industry, with at least 4 years of it in medical writing. Excellent command of written and spoken English. Good written and verbal communication skills. Knowledge of MS Office. Good organizational and time management ability. Excellent interpersonal and leadership skills. Scientific or clinical research or medical writing experience desirable. Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines.

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations Internal Relations Educational qualifications preferred Category Bachelor's Degree

Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Experience in doing external data reconciliation Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 205 b) To Apply for above Job Role ( Pune ) Type : Job Code # 206 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 207

SUMMARY Job Title: SAR & SAR-like Patient Safety Physician Reporting To: Patient Safety Physician SAR & SAR-like Coordinator Minimum Educational Qualifications and Experience Required Skills Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Operational Responsibilities Compile PBRERs with a focus on medical aspects and safety sections of products, and analyze safety trends, including source data analysis based on queries Assist in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborate with Therapeutic Head to identify signals and address product safety concerns Engage with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensure 100% compliance with timely completion of all client and Cognizant required trainings Achieve 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities

for Risk & Compliance New Associate Position Title:Risk & Compliance New Associate CL -13 Location: Bengaluru Employment Type: Full Time Must have skills : Risk & Compliance Good to have skills : Compliance About CF/S&C Corporate Functions include Human Resources, Finance, Legal, Marketing Communications, and Workplace Solutionsthat power Accenture's people across industries and functions to keep our business leading in the New. Join the heart and soul of Accenture, partnering with our extraordinary people to bring innovation into every organization. Combining unmatched experience and specialized skills across more than 40 industries, the company offers Strategy and Consulting, Song (Interactive), Technology and Operations servicesall powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. With net revenues of $64 billion for 2023, their 774,000+ employees deliver on the promise of technology and human ingenuity every day, serving clients in more than 49 countries and over 200 cities. Job Summary : The Risk & Compliance Manager is responsible for identifying, assessing, and mitigating potential organizational risks. They develop and implement risk management plans and ensure the organization complies with relevant laws, regulations, and internal policies. Roles & Responsibilities: Good Communication skills Candidate should have good excel skills. Adaptable and flexible Maintain and update compliance calendar, trackers, periodical reports, and repositories. Knowledge of labour Laws Strong analytical and problem-solving skills. Attention to detail and ability to work independently. Familiarity with regulatory requirements and compliance standards. Monitor and report on compliance issues and risks. Job Qualification: Additional Information: - The ideal candidate will possess a strong educational background in Law or a related field, along with good knowledge and experience in relevant country compliance. This position is based at our Bengaluru office. Qualification Experience: Minimum 1 - 2 year(s) of experience is required Educational Qualification: LLB

At OneStudyTeam (a Reify Health company), we specialize in speeding up clinical trials and increasing the chance of new therapies being approved with the ultimate goal of improving patient outcomes. Our cloud-based platform, StudyTeam, brings research site workflows online and enables sites, sponsors, and other key stakeholders to work together more effectively. StudyTeam is trusted by the largest global biopharmaceutical companies, used in over 6,000 research sites, and is available in over 100 countries. Join us in our mission to advance clinical research and improve patient care. One mission. One team. That s OneStudyTeam. As a Specialist, Source Configuration on our Trial Design team, you will have the important responsibility of ensuring that clinical research professionals effectively and correctly collect, manage, and safeguard the very source data that demonstrate whether an investigational product is safe and effective. In streamlining our source configuration and administration process to ensure top-notch implementation of our products, you will have an impact on making clinical trials more efficient and cost effective, thereby reducing clinical research as a bottleneck that constrains the availability of new life-enhancing and life-saving treatments. Your clinical research experience, attention to detail, and ability to troubleshoot issues will be key as you work independently to build, test, and publish electronic forms while meeting tight deadlines for multiple projects. This role offers the opportunity for the responsibilities to expand and develop with the organizations needs What You ll Be Working On Learn and maintain deep expertise in StudyTeam applications Review research protocols, CRF guidelines, and other stakeholder specifications to create accurate, comprehensive source form (CRF) templates Conduct and document thorough QA of source form templates Develop electronic forms, using Excel, from stakeholder specifications and feedback Build, test, and publish electronic source forms to maintain quality of the form design Support and coordinate user acceptance testing Collaborate with cross-functional teams to ensure successful execution of projects and provide feedback on product improvements to enhance our eSource product capabilities Help refine, document, and implement best practices for standardization, QA, and process improvement around source form creation and digitization What You Bring to OneStudyTeam 3+ years of relevant clinical research experience, including experience creating and/or QAing source document templates (CRFs) BA or BS, degree in business, science or related field, or AA degree and/or commensurate experience in relevant field(s) Prior experience owning successful execution of projects across teams, driving collaboration and successful completion, beyond an individual contributor status Experience working directly with clients (internal and/or external) and championing their long-term success Proven experience researching, learning, and utilizing new technologies and software Prior experience with a CTMS or other clinical research software tool is preferred Excellent communication (written and verbal), collaboration, and presentation skills Ability to thrive in a fast-paced, start-up environment - you are comfortable with ambiguity and find no job too big or small Extensive experience working with Excel Excellent organizational skills, attention to detail, and critical and creative problem solving skills Solution-oriented thinking, a zest for learning, and a willingness to help whenever needed Excellent time managements skills and the ability to prioritize multiple workloads Familiarity with CLI (Command-Line Interface) is a plus Experience with Python programming and GUI development (using Visual Studio Code) is a plus Business-level fluency in English We value diversity and believe the unique contributions each of us brings drives our success. We do not discriminate on the basis of race, sex, religion, color, national origin, gender identity, age, marital status, veteran status, or disability status. Note : OneStudyTeam is unable to sponsor work visas at this time. If you are a non-U.S. resident applicant, please note that OneStudyTeam works with a Professional Employer Organization. As a condition of employment, you will abide by all organizational security and privacy policies. This organization participates in E-Verify (E-Verifys Right to Work guidance can be found here ).

Job Title: Associate Global Development Scientist Director, Late Development Oncology Global Career Level: E Introduction to role: Are you ready to make a difference in the world of oncology? The Global Development Scientist is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT & GST members, Site Management & Monitoring (SMM), field based liaisons, and site personnel. The Global Development Scientist and counterpart Global Development Medical Director work collaboratively in the clinical aspects underpinning a clinical program. This includes the shared responsibility with Clinical Operations team members in the planning and execution, including recruitment and delivery of a clinical study. Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies. This includes providing clinical input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA). The Global Development Scientist may also provide expert input or lead functional process improvement initiatives and provide contributions to cross asset or cross tumor area working groups depending on the level of experience. As a key member of the clinical team, this position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements. Accountabilities: Clinical Development Responsibilities - Supports drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions. - Assists in the implementation of protocols and interactions with vendors and CROs, working closely within cross-functional team. Participates in the development of producing materials for investigator meetings (e.g., slides, booklets, and presentation materials). Assists in triaging and addressing questions regarding scientific and protocol procedures from other study team members and investigative sites. Serves as contact with vendors and CROs regarding medical/clinical science issues. - Support review of clinical data to identify and evaluate study data trends, outliers, protocol violators, etc., and write any necessary queries to be communicated to sites to ensure data accuracy and completeness of the assigned study. - Participate in safety review meetings regarding potential safety events within a given clinical study or across the assigned clinical program. Ensure updates to safety information are shared with cross-functional study team. Support review of safety narratives. - Supports preparation of abstracts, manuscripts, publications, and poster presentations of clinical study findings and results throughout the life cycle of the assigned study or product, as applicable. Supports medical affairs activities, payer and reimbursement activities. - Assists with drafting assigned sections of clinical reports, dossiers, and other documents. - Support Data Management in the build of the CRF and all associated instructions and plans (e.g., CRF completion instructions and Data Review Plan). Technical Skills - Basic understanding of drug development from molecule to market and demonstrates knowledge of scientific methodology in the design, conduct, and description of clinical research at a study level. - Ability to understand and contribute to the drafting of documents used throughout the clinical study lifecycle, such as site initiation materials, registration documents, protocols, and presentations. Demonstrates solid understanding of methodology in the design, conduct, and interpretation of clinical research. Outstanding attention to detail and outstanding written communication skills. - Serves as medical/clinical science representative on study team and collaborates cross-functionally on applicable deliverables during study life cycle (e.g., the protocol, CRF, data listings, TLF, CSR etc.) - Ability to analyze and summarize clinical results. Support creation of and review of clinical slides for internal and external meetings. Essential Skills/Experience: - Required Life Sciences degree or equivalent - PharmD, Ph.D. degree in life sciences, or MD preferred. Strong preference for Oncology experience - Industry or academic experience in drug development required. - Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research. - Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals. - Ability to grow and maintain a high level of expertise in oncology therapeutic area. At AstraZeneca, we are driven by a mission to transform cancer treatment through innovative approaches like novel biomarkers, AI, novel endpoints, and cutting-edge trial designs. Our collaborative environment empowers you to take smart risks and challenge norms while working alongside top experts globally. With one of the broadest oncology pipelines in the industry, youll have opportunities to work with new drugs that truly improve patient outcomes. Ready to join us on this exciting journey? Apply now to be part of our transformative team! 12-Jun-2025 17-Jun-2025

We are looking to add an experienced Clinical Writer to our team. The person in this position must be able to independently contribute to the development of initial and update(s) of CER’s that support the applicable regulatory submission requirements for the medical device products. An experienced Clinical Analyst professional has relevant medical/life-science qualification and knowledge/direct clinical experience in the use of the device or device type in a clinical setting. The expected experience is 7 - 8 years with a minimum of 4-5 years of CER writing experience is essential. A minimum of 4-5 years of medical writing/reviewing experience is needed. The experience is expected to be current or recent (preferably within the past two years), to provide confidence in their experience considering the rapid nature of updates/changes in the regulatory landscape, the device, its functionalities and the therapy area. Preferred EducationMasters’ degree in a life science or biomedical engineering discipline preferred, or equivalent regulatory/writing experience Preferred Experience: 1. The expected experience is 7 – 8 years with minimum 4-5 years of CER writing and reviewing experience as per EU MDR (European Union Medical Device Regulation (EU) 2017/745). Significant experience writing scientific, medical/clinical, and technical content. Also, a plus would be experience with writing CERs that conform to MEDDEV 2.7/1. 2. Knowledge in the therapeutic area – specifically in the field of diagnostic radiology, interventional radiology and radiation oncology 3. Familiarity with various country specific standards and regulations for medical devices to be able to assess and provide device appropriate clinical evaluation data for registrations.

Analysts engage in risk, compliance, and financial crimes projects to serve Promontory clients within the banking and finance industry – helping them meet and exceed regulatory expectations. Analysts are expected to positively contribute to Promontory’s success in a variety of areas, including BSA, anti-money laundering surveillance and reporting assistance, OFAC sanctions compliance, and other areas relevant to today’s heightened regulatory climate. Analysts must possess excellent writing, research, analytical, and critical thinking skills, and other applicable experience that leads to success in the role, such as strong work ethic and natural curiosity. Analysts must be able to judiciously analyze, assess, and write clearly and concisely. The nature of this work requires individuals to be flexible, learn new skills, work within time constraints, and meet uncompromising quality requirements and production expectations while working closely with others in a dynamic team environment. Apply logic and strong reasoning skills to conduct research for case analysis. Use sound decision-making skills to make recommendations based on research results. Compose comprehensive supporting narratives Interpret and apply project policies and procedures to direct work. Maintain high work product quality as outlined by each project specifications. Ensure work adheres to defined engagement policies and procedures Manage work efficiently to meet production goals and project deliverables. Contribute to developing individual and project goals and execute on tactical strategies for goal attainment. Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise 1+ year prior AML experience REQUIRED. Compliance experience at a financial institution is STRONGLY PREFERRED. Retail banking experience is PREFERRED. The ability to work independently, take initiative, and able to adapt to change. Ability to quickly understand and maintain current know3ledge of banking regulations, concepts, and issues. Quickly learn new applications and client systems to conduct research. Exercise sound judgment and observe the highest degree of confidentiality. Adept at multi-tasking and meeting deadlines in high-pressure environment. Results oriented team player with strong initiative and flexibility. Strong analytical and problem-solving abilities. Superior writing skills with the ability to convey ideas clearly and succinctly. Exemplary customer service towards both internal and external parties.

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS/MD Years of Experience: 3 to 5 years Language - Ability: English(International) - Proficient About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Performs Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports- Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals- Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP- Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables- Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable- Performs labelling of events of applicable cases- Provides Medical Expertise to case processing team whenever required- Provides training/mentoring to the team members wherever applicableCreate and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Understanding of PharmacovigialnceExperience in Medical Review of ICSRsMedical Review Roles and Responsibilities: - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals- Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP- Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables- Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable- Performs labelling of events of applicable cases- Provides Medical Expertise to case processing team whenever required- Provides training/mentoring to the team members wherever applicable Qualification MBBS,MD

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Title: Safety Data Exchange Agreement (SDEA) Drug Safety Specialist Job Summary: The SDEA Pharmacovigilance (PV) Specialist is responsible for managing Safety Data Exchange Agreements between the company and its partners in the contract management database, ensuring compliance with global pharmacovigilance regulations and facilitating efficient exchange of safety information, coordinating with various stakeholders, manage the lifecycle of SDEAs/PVAs for business relationships ensuring to meet the standard process and applicable regulatory requirements. Responsible to assess contractual information related to PV obligations on different type of reports like individual case safety reports, aggregate reports, signal reports, literature screening and other PV related aspects. Key Responsibilities : Management of Global and Local SDEAs (SDEA / PV clause / Pharmacovigilance Agreement / Vigilance Agreement, PV Agreement for Clinical Supply, Divestments) for investigational, post marketing, marketed products, vaccines and medical devices. Review and assessment of PV obligations from contracts on different type of reports ICSR processing and timelines, PSURs/PBRERs, RMPs, Signal detection, Clinical study reports, periodic line listings, literature screening, labeling etc. to ensure accurate information is entered in the database. Management of Safety database related configuration requests and updates. Build and manage reports (Business Partner lists) periodically from the Contract management database to provide the operational functions with the latest contacts list for implementation in their processes or systems Maintain a database of all agreements and track their status, expiration dates, and amendments. Provide guidance on SDEA-related issues to stakeholders and non-stakeholders. Ensure timely execution of SDEAs in the database to support project timelines. Strict adherence to the standard operating procedures (SOPs) and guidelines. Ensure all executed PVAs and its Main agreements are tracked within Global Comprehensive tracker and filed within dedicated share folder. Provide support in ad-hoc activities to support the periodic aggregate teams for preparation of PSURs/DSURs Efficient in mailbox management and reconciliations. Conduct training sessions on SDEA processes and requirements for relevant staff. Perform Quality check on the processed data entries. Monitoring of Key performance indicators (KPIs) and metrics. Stay current with global pharmacovigilance regulations and industry best practices. Participate in audits and inspections related to safety data exchange processes. Qualifications: Bachelor's degree in Life Sciences, Pharmacy, or a related field. Advanced degree preferred. 2-3 years of experience in pharmacovigilance, clinical research, or a related field. Knowledge and Experience : Related experience in drug safety/ pharmacovigilance and contract (SDEA/PVA) management is desirable Strong knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, EMA, FDA). Strong knowledge of pharmacovigilance terminologies on Individual case safety reports, Aggregate safety reports, Signal and risk management, and related regulations and guidelines (e.g., ICH, EMA, FDA). Strong knowledge about the master service agreements and terminologies. Experience in management of the ICSRs in safety database. Understanding of medical terminology and adverse event coding. Experience in automation / artificial intelligence would be an asset. Desired Skills: Sound knowledge of drug safety, data analysis and evaluation of safety data Ability to work collaboratively and effectively in a team environment Client focused approach to work Ability to evaluate data and draw conclusions independently Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Computer proficiency, IT skills, the expertise and ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)

About the role: The Senior Regulatory Start Up Associate is primarily responsible for planning, preparation, review of country and site level ethics and regulatory authority applications and submissions during project start-up, in compliance with ICH-GCP and local regulatory requirements, to ensure timely clinical trial approval. Minimum Qualifications Experience: Graduate in a clinical, pharmacy or life sciences related field. At least 3-5 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment. Responsibilities: Serve as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. Provide expertise and guidance to RSM and/or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries. Work within the scope of the Regulatory Start-Up plan or other applicable project plan, relevant SOPs, and ICH-GCP. Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate. Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals. May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities. Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Ensure submission packages are accurate and complete per local requirements. Review and follow-up on comments/questions raised by reviewing bodies and advise/contribute to response. Submit response with Client approval within timeframe. Follow submission, application to approval. May serve as a point of contact for Regulatory Authorities, Ethics Committees/Review Boards and other local authorities. Prepare and submit ongoing amendments, notifications, safety reports and study related materials required by Regulatory Authorities, Ethics Committees/Review Boards and other local authorities as per local requirements. Escalate any issue to the RSM and/or PM and provides rationale for submission/approval delays, and contingency plan to mitigate impact. Perform country and site Informed Consent Form (ICF) customization in line with local requirements. Initiate translation of submission documents as applicable and review translated documents before submission. Review and approve proposed packaging and labelling for clinical trial material. Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required. Register project onto an official clinical trial registry as agreed to with Client and update status as required. Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensures accuracy and completeness of these documents. Serve as an independent essential document reviewer and performs 2nd review of Activation Forms for IP release if required. Where applicable, may act as a Country Lead for projects with no RSM. At least 3-5 years Regulatory Start-up experiences in clinical industry. Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Participate in company start-up initiatives, contributing to development and maintenance of regulatory start-up processes, tools and SOPs. Identify areas of inefficiency in process and make recommendations for improvements. Assist with RSA training in the development and delivery of training in conjunction with Learning and Development Manager and serve as a mentor to junior RSAs. Serve as the local subject matter expert on specialized aspects of regulatory and start -up activities. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications Experience: Graduate in a clinical, pharmacy or life sciences related field. At least 3-5 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment. Responsibilities: Serve as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. Provide expertise and guidance to RSM and/or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries. Work within the scope of the Regulatory Start-Up plan or other applicable project plan, relevant SOPs, and ICH-GCP. Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate. Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals. May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities. Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Ensure submission packages are accurate and complete per local requirements. Review and follow-up on comments/questions raised by reviewing bodies and advise/contribute to response. Submit response with Client approval within timeframe. Follow submission, application to approval. May serve as a point of contact for Regulatory Authorities, Ethics Committees/Review Boards and other local authorities. Prepare and submit ongoing amendments, notifications, safety reports and study related materials required by Regulatory Authorities, Ethics Committees/Review Boards and other local authorities as per local requirements. Escalate any issue to the RSM and/or PM and provides rationale for submission/approval delays, and contingency plan to mitigate impact. Perform country and site Informed Consent Form (ICF) customisation in line with local requirements. Initiate translation of submission documents as applicable and review translated documents before submission. Review and approve proposed packaging and labelling for clinical trial material. Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required. Register project onto an official clinical trial registry as agreed to with Client and update status as required. Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensures accuracy and completeness of these documents. Serve as an independent essential document reviewer and performs 2nd review of Activation Forms for IP release if required. Where applicable, may act as a Country Lead for projects with no RSM. At least 3-5 years Regulatory Start-up experiences in clinical industry. Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Participate in company start-up initiatives, contributing to development and maintenance of regulatory start-up processes, tools and SOPs. Identify areas of inefficiency in process and make recommendations for improvements. Assist with RSA training in the development and delivery of training in conjunction with Learning and Development Manager and serve as a mentor to junior RSAs. Serve as the local subject matter expert on specialised aspects of regulatory and start -up activities.

full-service in scope, across all clinical trial phases. With support from Senior Project Manager, ensure all project work is completed to the sponsors satisfaction, on time and within budget and in accordance with policies and procedures. Essential Functions Under supervision, plan, initiate, execute, control, and deliver projects in accordance with the Scope of Work agreed with the customer. Lead the Connected Devices cross-functional teams to ensure successful delivery of assigned projects. Ensure that consistent and appropriate project specific guidelines are documented and circulated to all project team members and that the team is well-trained on these guidelines. Track project progress, identify and evaluate project risks and take advice from superiors on corrective action as appropriate. Prepare and present project information at internal and external meetings. With guidance, manage the project financials accurately and appropriately ensuring project goals are achieved according to customer s expectations and within the scope of the project. Ensure revenue recognition and forecasts are calculated accurately and change orders executed where appropriate. Conduct an End of Project review meeting to ensure that all project activities have been completed in full. Keep Connected Devices leadership fully informed of any project issues that may impact quality, budget, and timeliness of project delivery to the customer s satisfaction. Request support and advice for timely issue resolution as required. Provide input to line managers on their project team members performance relative to project tasks to aid career development. Qualifications Bachelors Degree Life science or health care related discipline Pref Three years industry experience Pref Or Equivalent combination of education, training and experience Pref Good leadership skills Good ability to prioritize, schedule and organize Good interpersonal and communication skills Good problem solving skills Excellent customer service skills Good Microsoft Office skills Ability to establish and maintain effective working relationships with coworkers, managers and clients

Clario s medical imaging expertise is unparalleled in the industry. With over 30 years of experience, we provide seamless, secure, and compliant medical imaging solutions that optimize clinical trials. Our commitment to excellence has made us a leader in the medical imaging core lab sector. We are seeking dedicated and skilled Medical Imaging Technologists to join our growing operations team in India. What we offer Competitive compensation (fixed + variable) Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Our Medical Imaging Technologists ensure Quality, including Protocol Compliance and Technical Adequacy, of Image Data by: Reviewing and analysing image data for clarity and quality Verifying image data is in compliance with project protocol requirements Generating image queries when needed Working with therapeutic team to notify Sponsor/Site for proper resolution of quality issues Assisting in archiving data for completed projects Performs other image analysis functions as may be required by: Performing client or internal demonstrations of image processing Reviewing and preparing images for submission to client and/or agency Identifies and communicates Project Requirements as they relate to the image quality review (IQR) processes by Reviewing evaluations of potential clinical research sites and verifying the accuracy of information pertaining to site personnel, medical imaging equipment, imaging protocol and data archival capabilities Providing support for technical imaging related issues Performing study initiation/technical visits to educate site personnel on image acquisition protocol, data archival, and data transmittal procedures including form(s) completion Assisting in the design and implementation of study related forms Assisting in writing and reviewing imaging guidelines/manuals Assisting in reviewing Site Surveys Maintains Quality Service and Departmental Standards by Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs) Assisting in establishing and enforcing departmental standards Participating in user acceptance testing for new tools and software enhancements Participating in the modification of company SOPs related to IQR What we look for Bachelor s degree preferred 2+ years as Imaging Technologist in a imaging center or relevant clinical trial experience preferred Experience with PET is preferred Experience with X-Ray, MRI & CT modalities advantageous Experience working with computer software including Word, Excel and Access preferred Experience working with clinical trials and/or within pharmaceutical environment preferred Individuals who are able to work remotely and open to European and US time zone working hours

ob Overview Conducts quality assurance testing of medium to high complexity software applications.Designs, develops, implements and updates software systems in accordance with the needs of the organization. Evaluates, schedules, and resources development projects; investigates user needs; and documents, tests and maintains computer programs. Essential Functions Carries out procedures to ensure that all information systems products and services meet minimum organization standards and end-user requirements. Defines master test plans to document overall testing strategy for a project. Thoroughly tests software to ensure proper operation and freedom from defects prior to implementation. Documents all problems. Implements improvements to current procedures and develops models of possible future configurations. Performs work flow analysis and recommends quality improvements. Establishes quantitative measurements and techniques for measuring software quality. Establishes, with assistance, advanced software test standards and methods and conducts complex software tests. Participates in review and evaluation of software quality assurance products and services for applicability to in-house needs. Assists with selection of software test engineers for assignment to projects. Mentors and sometimes manages more junior level test engineers. Qualifications Bachelors Degree Computer Science, a related field or equivalent experience Req Five (5) years related experience in quality assurance and testing Req

Job Description Overview Join global organization with 82000+ employees around the world, as a ETL Data Brick Developer role based in IQVIA Bangalore. You will be part of IQVIA s world class technology team and will be involved in design, development, enhanced software programs or cloud applications or proprietary products. The selected candidate will primarily work on Databricks and Reltio projects, focusing on data integration and transformation tasks. This role requires a deep understanding of Databricks, ETL tools, and data warehousing/data lake concepts. Experience in the life sciences domain is preferred. Candidate with Databricks certification is preferred. Key Responsibilities: Design, develop, and maintain data integration solutions using Databricks. Collaborate with cross-functional teams to understand data requirements and deliver efficient data solutions. Implement ETL processes to extract, transform, and load data from various sources into data warehouses/data lakes. Optimize and troubleshoot Databricks workflows and performance issues. Ensure data quality and integrity throughout the data lifecycle. Provide technical guidance and mentorship to junior developers. Stay updated with the latest industry trends and best practices in data integration and Databricks. Required Qualifications: Bachelor s degree in computer science or equivalent. Minimum of 5 years of hands-on experience with Databricks. Strong knowledge of any ETL tool (e.g., Informatica, Talend, SSIS). Well-versed in data warehousing and data lake concepts. Proficient in SQL and Python for data manipulation and analysis. Experience with cloud platforms (e.g., AWS, Azure, GCP) and their data services. Excellent problem-solving skills. Strong communication and collaboration skills. Preferred Qualifications: Certified Databricks Engineer. Experience in the life sciences domain. Familiarity with Reltio or similar MDM (Master Data Management) tools. Experience with data governance and data security best practices.

Are you seeking a purposeful and rewarding Project Management career opportunity within a team dedicated to specialty solutions for clinical trials Our Clinical Adjudication team is expanding in India, and with ambitious goals and a clear vision for the future, now is the perfect time to join Clario as a Clinical Project Manager. In this role, you will be part of a team dedicated to ensuring unbiased and standardized evaluation of clinical trial events, contributing to the credibility and success of our studies. Join us and make a meaningful impact in the field of clinical research. What we offer Competitive compensation + shift allowances Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Identifies project guidelines and communication needs by: Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documents Defining project plans (i.e. timelines, milestones and limitations for project staff) Establishing project reporting schedules Providing project updates to BD Director, Global Services Managing Directors, Sponsor representative(s) on schedule Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s) Performs project analysis and management by: Identifying critical project success factors for tracking, analysis and reporting Determining needed resources for project completion and communicating needs to appropriate departmental managers Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost management Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting Understanding SOPs and working closely with QA for clarification and documentation of deviations Training and maintaining project team knowledge and applications of SOPs Communicating all protocol clarifications/revisions to project team Coordinating site management of data collection with internal and external teams Provides project team leadership by: Leading by example with professional and collaborative conduct Developing and delivering team project training Establishing team performance expectations and guidelines Providing input to departmental managers of respective team members performance level Analyzing team performance for consistency/quality within established project guidelines Collaborating with the departmental managers for team coaching/mentoring Supports Business Development efforts by: Collaborating with BD Director in the development and presentation of company capabilities calls/meetings Attending professional meeting(s) as Company representative Delivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company services Oversees project close out by: Assisting with coordination of submission activities, as applicable Assisting with initiating and overseeing all project close out activities to completion Performs supervisory functions by, if applicable: Communicating job expectations Planning, monitoring and appraising job results Coaching, counseling and disciplining staff Initiating, coordinating and enforcing systems, policies and procedures Approving direct reports time sheets, requests for time off and/or overtime Performing timely performance evaluations of direct reports Coordinating and conducting new hire interviews; facilitating hiring decision Training new hires on departmental processes and responsibilities Maintains Quality Service and Departmental Standards by: Reading, understanding and adhering to organizational Standard Operating Procedures ( SOP ) Establishing and enforcing departmental standards Reviewing and updating company SOPs related What we look for Bachelor s degree required or commensurate experience level. Educational majors in life sciences, pharmacy, nursing, or other healthcare field highly desirable Previous management or project experience in clinical development of investigational medications required 1-3 years clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a project management related role. Working knowledge of GCH, ICH guidelines and FDA regulations Clinical Adjudication experience a plus Experience working with computer software including Word, Excel, Access and Project preferred Strong interpersonal and communication skills, both verbal and written Strong organizational and leadership skills Goal oriented Ability to maintain professional and positive attitude

Job Overview Support the continuous improvement of the staffing function through development and implementation for all staffing programs in an assigned business unit/department, primarily in one geography. With guidance, conduct recruiting activity for management teams as assigned. Essential Functions Work with management in assigned service areas, business units or departments to source, select and hire qualified candidates to fill vacant positions using cost-effective techniques and in accordance with company policies, procedures and processes. Write job postings to post and advertise positions. Review applications and conduct interviews to obtain information regarding applicants work history, education, training, job skills, and salary requirements. Create and coordinate job advertising in various media. Attend job fairs and develop and maintain contacts with colleges, universities, alumni groups, and other organizations to identify potential applicants. Work with external recruiters and employment agencies to identify and recruit candidates. Utilize Internet online recruiting sources to identify and recruit candidates. Meet with functional business leaders and executive management, as required, to discuss and establish staffing objectives and ensure they are achieved. Assist with training line management on recruiting, interviewing, and the selection process as required. Support a diverse workforce and comply with local and regional hiring guidelines and procedures, particularly for applicant tracking. Keep abreast of market trends and demands impacting the company s ability to attract competitive candidates; coordinate with the compensation team on salary offer considerations and equity concerns. Ensure the provision of timely employee-related information to management teams as necessary. May be responsible for meeting established financial targets and assisting with business development activities depending on business line. Qualifications Bachelors Degree Req 1 year experience within a staffing function as a recruiter or combination of recruiter and specialist experience Req Or Equivalent combination of education, training and experience Req Sound knowledge of legislation in the recruiting process Strong computer skills including Microsoft Office applications and HRIS applications Strong verbal and written communication skills Strong attention to detail Good problem-solving, judgment and decision-making skills Good understanding and awareness of the commercial environment and market trends Good customer service skills Very high degree discretion and confidentiality Ability to multi-task, prioritize and plan routine activities Ability to establish and maintain effective working relationships with coworkers, managers and clients . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Job Overview Oversee a team of clinical database design professionals for delivery and build of multiple studies in various platforms. May act as a client contact from clinical database designing team responsible for project financials, new scope of work, relationship development. May also act as a SME for IT team for s/w application maintenance adoption. Essential Functions Global SME role. May act as a global librarian. Supports and performs CAPA, escalations and issues identified. Performs project financials check review. Define and prioritize resource requirements and manage resource assignments across projects. Implement department/office objectives. Peer review of task at portfolio level. Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers. Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency. Participate in the development and implementation of new processes and technology. Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work. Identify and address professional development/training needs of staff. Mentor staff members to develop Data Management programming process, system, and drug development expertise. Provide design programming input into proposals and scope of work. May participate in proposal defenses. Attend customer meetings and lead discussions of project programming requirements and strategic planning. Understand scope of work, budget, and scope assumptions. Identify out of scope work and provide revised costs with supporting documentation. Ensure project milestones are met according to agreed upon timelines. Actively manage quality throughout project. Responsibilities include planning, assigning, and directing work. Qualifications Bachelors Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req 4-6 years of relevant core Technical designer experience and total exp being 9+ yrs. Req . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com