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1.0 - 3.0 years
3 - 5 Lacs
kozhikode
Work from Office
Responsibilities: * Lead healthcare operations team * Ensure compliance with regulatory standards * Optimize resource utilization * Manage hospital administration & clinical ops * Collaborate with stakeholders on strategic planning
Posted 3 weeks ago
1.0 - 2.0 years
0 Lacs
mumbai
Work from Office
Biostatistician Responsible for statistical tasks in clinical trials including design, analysis, reporting, SAPs, and meta-analyses. Provide consultation, ensure quality deliverables, support publications, and comply with GCP/regulatory guidelines.
Posted 3 weeks ago
7.0 - 12.0 years
6 - 15 Lacs
noida
Work from Office
Role & responsibilities Manage and organize office operations and procedures. Handle incoming calls, emails, and other communications. Schedule meetings, appointments, and travel arrangements. Maintain and update company databases, records, and filing systems. Preferred candidate profile Experience with office management software. Knowledge of basic accounting and budgeting procedures. Familiarity with HR practices and procedures.
Posted 3 weeks ago
10.0 - 20.0 years
8 - 12 Lacs
thiruvananthapuram
Work from Office
We are looking for enthusiastic and dynamic candidates who have strong background of hospital end to end operational administration capacity, interested candidates send resume to headhr@yanaivf.com to discuss in detail about the role.
Posted 3 weeks ago
3.0 - 8.0 years
5 - 10 Lacs
mumbai, mumbai suburban, navi mumbai
Work from Office
Hiring For Mumbai Andheri Designation- Client Consultant / Sr. Client Consultant 5 days Working Weekends off Work from office Cabs- Both side US Shifts Must have knowledge on oncology and ASC Billing Package Upto 10LPA Required Candidate profile Contact To Apply HR Priyanka-9816787033 HR Ridhi- 8178280056 HR Deepali- 9650092537
Posted 3 weeks ago
10.0 - 15.0 years
20 - 30 Lacs
hyderabad
Hybrid
Job Summary: We are looking for a highly skilled and experienced Clinical Research Scientist with a strong background in Bioequivalence and Bioavailability (BE/BA) studies and clinical operations . The ideal candidate will have over 10 years of experience in the pharmaceutical industry, with a minimum of 7 years in BE/BA studies, and a deep understanding of regulatory requirements for highly regulated markets including USFDA, EMA (EU), and Health Canada . This role also involves overseeing clinical trials as a Sponsors Representative , managing end-to-end clinical processes, ensuring regulatory compliance, and coordinating with various stakeholders for successful study execution and documentation. Key Responsibilities: BE/BA & Regulatory Focus: Design and oversee Bioequivalence and Bioavailability studies across various dosage forms. Ensure strict compliance with regulatory standards (USFDA, Health Canada, WHO). Develop and review study protocols, SOPs, ICFs, and Clinical Study Reports (CSRs). Coordinate with CROs, bioanalytical labs, and internal teams for timely project execution. Interact with regulatory agencies and provide scientific responses to queries/deficiencies. Monitor regulatory trends and update internal SOPs and processes accordingly. Clinical Study Operations: Serve as Sponsors representative in assigned clinical studies, ensuring ethical and procedural compliance. Oversee dosing of study subjects , subject safety follow-ups , and ensure adherence to ICH-GCP. Review and compile raw clinical data, ensure proper monitoring and quality control (QC) . Prepare clinical updates , confinement reports , clinical summary reports , and ensure accuracy of clinical documentation. Review and finalize study documents, then hand over to QA for further processing. Support in EC submissions of protocols and related documentation. Manage study initiation , execution , archival , and retrieval of clinical records. Address and close QA/Sponsor queries and observations. Required Skills & Competencies: Deep understanding of ICH-GCP and regulatory guidelines (USFDA, CDSCO, Health Canada, WHO). Strong background in pharmacokinetics, clinical study design, and regulatory documentation. Ability to perform both strategic planning and hands-on clinical trial execution. Proficiency in clinical data handling, document management, and compliance tracking. Preferred Candidate Profile: Strong interpersonal skills and leadership qualities. Exposure to complex generics and/or challenging dosage forms is an advantage. Educational Qualifications: B.Pharm , M.Pharm , and Ph.D. in Pharmaceutical Sciences, Clinical Research, or a related field
Posted 3 weeks ago
2.0 - 7.0 years
2 - 2 Lacs
noida
Work from Office
Website: https://zenplus.in/about-us/ Key Responsibilities: Operations Management * Oversee daily operations of ambulance services across districts * Ensure optimal deployment, availability & response time of ambulances * Monitor KPIs: vehicle uptime, response time, and service quality Team Leadership * Supervise and support drivers, paramedics, fleet executives, and staff * Conduct regular team meetings, training sessions, and performance reviews Fleet & Maintenance Coordination * Schedule routine maintenance to ensure vehicle roadworthiness * Coordinate with garages, fuel providers & GPS monitoring vendors * Ensure cleanliness, equipment, and readiness of all ambulances Compliance & Reporting * Adhere to statutory and operational guidelines * Maintain MIS reports, shift schedules, fuel logs, and service records Stakeholder Coordination * Liaise with control rooms, hospitals, and government health officials * Resolve service issues, grievances, and emergency escalations promptly Emergency Response * Lead operations during crises, mass casualty incidents, or breakdowns * Implement SOPs for disaster and emergency response situations
Posted 3 weeks ago
15.0 - 20.0 years
100 - 125 Lacs
bengaluru
Work from Office
Job role To enable organisations emergence as a world class R&D organization, the Site Management and Monitoring (SMM) Country/District COM plays a leadership role accountable for driving the businessof SMM within a Country/District(s) by providing oversight and direction to SMM staff; accountable for the on time, within budget and quality delivery of the clinical studies. Promotes best practice; identifies infrastructural improvements and implements action plan to ensure Clinical Field Operations (CFO) and business objectives are successfully met; ensures alignment of local activities with regional/global initiatives. The role reports into the Site M&M Leadership and serves as a single point of accountability for the SMM deliverables within a Country/Disitrct(s) and influences and aligns within Development Operations, and with Global Medical Affairs (GMA), and other key stakeholders across the organization. Responsibilities : Manages/oversees site/country or district related activities as they relate to clinical studies (e.g. country feasibility, site evaluation/selection and activation, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, site closure). Accountable for the on-time and within budget execution of all clinical trials within a Country/District(s). Provide local regulatory and legal requirement expertise. Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Monitor regulatory reforms and industry trends within country / region. Conduct and/or implement impact analysis of all significant changes to conform with updated regulatory / industry regulations affecting conduct of clinical studies. Always ensures audit and inspection-readiness Country contact for regulatory agency questions related to monitoring processes and procedures. Drive CAPA preparation and implementation. Accountable for managing country/district resources including need identification, timely hiring and Accountable for managing country/district resources including need identification, timely hiring and allocation, and managing changes to hiring plan. Responsible for staff recruitment and retention plans. Accountable for functional budget planning and administration. Provide leadership to the Country/District and be accountable for growth and development of a Qualifications : Education : Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred. Site Monitoring Experience : Minimum 3 years. Preferably having monitored and/or managed a study within a Country from start to close. Experience in functional budget planning, resource planning & assignment, quality management in a Country lead capacity preferred. At least 2 years of experience in line management of staff including acquisition of talent, performance management, growth and development, managing employee relations, coaching and mentoring of staff and teams preferred. Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making. Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player. Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with experience leading (within country or region) projects with competing deadlines; Experience across multiple Therapeutic Areas and Study Phases. to apply share resumes with Puja.k@maxisclinical.com Regards Puja Khemchandani
Posted 3 weeks ago
1.0 - 6.0 years
9 - 13 Lacs
bengaluru
Work from Office
About The Role Job Title - Research & Development Consultant Life Sciences Management Level :09,11 Location:Bangalore/ Gurgaon/Hyderabad/Mumbai Job Summary : MBA from a Tier 1 institute or rich relevant industry experience 6+ years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences industry is mandatory Management consulting and general business consulting experience is a must Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable About Our Company | Accenture (do not remove the hyperlink) Qualification Must have skills:R&D, Pharmacovigilance, regulatory Reporting Good to have skills:Core LS consulting Experience:Minimum 2 year(s) of experience is required Educational Qualification:B.Tech/BE + MBA mandatory
Posted 3 weeks ago
10.0 - 15.0 years
4 - 6 Lacs
ghaziabad
Work from Office
Key Responsibilities Responsibility AreaKey Duties1. Nursing Administration Lead nursing staff across shifts; manage staffing, scheduling, and manpower allocation 2. Quality & Accreditation Drive compliance with NABH standards; coordinate internal audits and accreditation preparation 3. Patient Care Oversight Ensure nursing care delivery aligns with policies; monitor critical patient care and escalation protocols 4. Training & Development Mentor nursing staff; organize regular training sessions on clinical best practices and hospital protocols 5. Policy & Procedure Management Update nursing SOPs, enforce uniform standards and hygiene compliance across wards and departments 6. Collaboration & Coordination Liaise with multidisciplinary teams (doctors, nursing, housekeeping, admin) for smoother patient care delivery 7. Documentation & Reporting Maintain up-to-date reports on staffing, nursing indicators, incident logs, and audit findings 8. Resource Management Monitor nursing supplies, budgets, and equipment; ensure adequate stock and maintenance Skills & Competencies Leadership & Team Management : Strong coordination with diverse nursing teams NABH & Quality Assurance : Skilled in accreditation processes and audits Decision Making & Crisis Management : Calm and effective under pressure Communication & Coaching : Able to guide teams and communicate with clarity Analytical Thinking : Data-driven insights for performance and improvement planning Regulatory Knowledge : Informed on healthcare compliance, labor laws, and hospital regulations Qualifications & Experience Required : B.Sc. Nursing with valid registration; Master's in Nursing (desired) Experience: 1015 years in hospital nursing administration Proven exposure in NABH processes, quality audits, and compliance management Salary & Benefits Offered Salary : 55,000 per month Additional benefits: As per hospital’s HR policy Contact no-8588047050
Posted 3 weeks ago
15.0 - 24.0 years
0 - 0 Lacs
raipur
Work from Office
Role and Appointment of Medical Superintendent (MS) under NMC The Medical Superintendent is the senior administrative head responsible for the overall management and smooth functioning of the hospital. The MS oversees infrastructure, staffing, budgeting, compliance with NMC norms, and coordination among departments. As per the latest NMC regulations, the MS typically must: Have a strong medical background, Be experienced in hospital administration and management.
Posted 3 weeks ago
1.0 - 6.0 years
2 - 6 Lacs
kochi
Work from Office
- Successfully complete our internal training plan to include hemodynamics, ECG, angiography, echo CT imaging modalities and complete the case support and proctor delegate authorizations. - Provide active commercial case support, demonstrating excellence in procedural success rates patient outcomes. - Scrub in sterile and provide TAVI valve loading in procedures training instruction to trial and commercial customers - Provide our customers CT valve sizing analysis utilizing the Pie Medical 3Mensio CT program - Lead customer didactic education sessions for account activation before first implants - Lead pre case planning debriefing of heart team pre post procedure and provide ongoing education as requested for proper in - service levels - Provide documentation as required for quality assurance initiatives - Co-develop commercial business plan for assigned region - Co-support internal/external quarterly business reviews - Data entry into Salesforce, Mentor software for customer case support management - Learn commercial data analytics, resources tools for effective customer experience - Support customer engagement strategy with Marketing team (TM)) - Demonstrate competency with marketing messaging, clinical evidence and medical education portfolio offering - Demonstrate knowledge in the TAVI market, industry competitive insights - Participate in team meetings, conventions, and national sales meetings as requested - Drive innovative marketing and referral activities in collaboration with the markeitng team - Collaborate with the Sales and marketing team to conduct targeted market development in India Sub-continent. - Lead organization and delivery of key symposia by supporting discussions with customers to define agenda topics, select appropriate speakers / chairs, create required materials for events. - Develop Key Opinion Leaders within this segment to create market for the new therapies which will be launched and create advocates for your product who will speak on various forums - Identify high potential international / national referral community meetings to target for market development and collaborates with sales management team to put forward case for investment (program contributions / symposiums / workshops)
Posted 3 weeks ago
7.0 - 10.0 years
3 - 15 Lacs
pune, maharashtra, india
On-site
Job Summary: Collaborate in a Functional Service Provider or Full-Service environment to support clinical development processes. Contribute to streamlining workflows, simplifying operations, and delivering therapies efficiently. Work in a dynamic, team-oriented environment, supporting customer goals and operational excellence. Key Responsibilities (Implied / Typical): Collaborate with internal teams and external stakeholders to achieve project objectives. Support operational processes in clinical trials or service delivery. Contribute to process improvements and workflow simplification. Assist in data management, reporting, or document tracking as required. Maintain compliance with relevant SOPs, guidelines, and regulations. Support discovery calls, meetings, and coordination with project teams. Qualifications: Education and experience to be confirmed during discovery call. Likely requirement: experience in clinical operations, project management, or related functional service roles.
Posted 3 weeks ago
1.0 - 4.0 years
3 - 6 Lacs
bengaluru
Work from Office
Support clinicians with coordination, reporting, audits & training; ensure compliance, accuracy & efficiency across dental practices.
Posted 3 weeks ago
1.0 - 5.0 years
3 - 3 Lacs
faridabad
Work from Office
Roles & responsibilities- Operating X-ray equipment safely and effectively to produce high-quality images. Explaining procedures to patients, addressing their concerns, Positioning patients and equipment to obtain optimal views of the targeted area. Adhering to radiation safety guidelines Maintaining patient records. Working with radiologists, physicians, and other healthcare professionals Ensuring proper functioning of X-ray equipment. To take care of operations of the center by optimum utilization of resources & operation efficiency in order to provide smooth & uninterrupted services to the stakeholders. Preferred candidate profile- Proficiency in operating X-ray equipment, including understanding of radiation safety principles. Good communication and problem-solving skills Attention to Detail Perks- PF, mediclaim, insurance
Posted 3 weeks ago
7.0 - 10.0 years
10 - 14 Lacs
saharanpur, up
Work from Office
OVERALL PURPOSE OF THE ROLE: The Line Manager Is responsable to support the Operations Manager to deliver the service demandes of the DEPOT by leading and facilitating effective team working among the team members for servicing / planned maintennece and renovation/modernisation/corrective maintenance activity. The purpose of the job is to Manage all the maintenance activities (PM/ CM/ A&V) in the Line/Workshop including the responsibilities linked to the position as hierarchical manager of the employees of the Maintenance organization who belong to this Line/Workshop RESPONSIBILITIES: Team Management Lead all aspects of the team in the maintenance, servicing to meet customer requirements within the working timetable. To deliver Start of shift Briefing (SOSB) / End of shift briefings to team members (EOSB). To be responsible for the deployment of team members in line with the shift throughput requirements. Co-ordinate line of route ensuring that equipment, tooling and work environment is left in a safe place Assist Operations Manager as required to ensure business needs are maintained. Leading and prioritising workloads agreed with the Operations Manager. EHS -Responsible for leading team members to uphold site safety, including reporting of any unsafe acts, process/procedure deviation Performance Provide real time updates to the Operations Mananger on work progress against the agreed plan, SQDC deviations and adverse events. Ensure that all worksheets are correctly provided to the required standard Completion of the shift paperwork 100% (exam, daily, safety sheets) in Service Excution Ensure that the team follow the standard processes and conform to those standards on the job. Ensure all documentation and procedures are at the correct revision and signed off in full when completed. Team Communication Conduct regular informal discussions with team members. Provide regular feedback on team / individual performance. Be proactive in seeking views and input from team members. Team Continuous Improvement Take a proactive approach to support Operations Manager in understanding and resolving team issues. Demonstrate an awareness of continuous improvement, team development and best practice. Carry out audit of processes to ensure feedback from team members to continually improve the process or procedures. Support the Operations Manager in proactively working towards a reduction in Non-Value Added activities. Support the team to identify process changes and implement smarter ways of working, engage with APSYS and Industrial Teams Ensure 5S is fully implemented Ensure Special process compliance and SES excution Team Development Ensure all team members have skills including Special Process training needed to perform and deliver against the work plan. Conduct regular review of skills matrix for team members. Identify individual training needs and report to Operations Manager Encourage kaizen schemes and 5 S awards KPI: Consistent SQCD achievement of train maintenance availability and reliability targets in accordance with project deliverables Consistent SQCD achievement for renovation/modernisation activity Ensuring 5S is deployed and maintained Compliance with IFR in accordance to defined standard Qualifications & Skills: EDUCATION BE or B TECH Regular course in Electrical or Mechanical Engineering BEHAVIORAL COMPETENCIES: Respect of target task time in compliance with maintenance procdures. Respect of EHS and Quality policies. Continuous improvement of tasks executions. Team Player. Spirit of Team Trust Action Good written and verbal communication skills Problem resolution skills Self-motivated Ability to work under own initiative and to stringent timelines IT literate TECHNICAL COMPETENCIES & EXPERIENCE 1. Experience of working in Rolling stock maintenance mainline (PREFERABLY 7-10 years) 2. In-depth understanding of the rail depot and rail industry operations. 3. Proven experience in fleet and/or maintenance and/or renovation within an operations role 4. Ability to work and lead a team. 5. Knowledge of Network rail Rules and Regulations 6. SAP - GSI exposure LEADERSHIP SKILL AGILE Dealing with uncertainty Business Acumen Innovative Learning on the fly INCLUSIVE Building effective (virtual) teams Listening and informing Managing diversity Understanding others with empathy RESPONSIBLE Customer focus (internal and external) Integrity and ethics Managerial courage Managing with vision and purpose. EXPERIENCE / SKILL SET Language Skills: Proficient in English language & Hindi. IT Skills: MS office tools (Word, Excel, PowerPoint), SAP An agile, inclusive and responsible culture is the foundation of our company where diverse people are offered excellent opportunities to grow, learn and advance in their careers. we are committed to encouraging our employees to reach their full potential, while valuing and respecting them as individuals.
Posted 3 weeks ago
2.0 - 6.0 years
2 - 6 Lacs
pune, maharashtra, india
On-site
We are seeking a proactive Clinical Operations Specialist to join our team. This role is essential for safeguarding the wellbeing of research subjects and ensuring all clinical procedures are executed with the highest standards of care and in full compliance with all protocols and regulatory guidelines. Roles and Responsibilities Safeguard the wellbeing of research subjects in a medical capacity. Review study protocols and execute procedures in alignment with protocols and regulatory, health, and safety standards. Recruit and coordinate communication with clinical trial volunteers and patients, maintaining clear and effective communication throughout the study. Follow all applicable regulations globally and by region. Collaborate with cross-functional teams to develop study materials, including informed consent forms and study manuals. Monitor trial progress and address any issues that arise during the study. Provide organizational support and assist with administrative tasks as needed. Perform routine tasks with some deviation from standard practice, adapting to changing circumstances. Utilize broad knowledge of operational systems and practices to improve study processes and outcomes. Skills Required Strong understanding of clinical research protocols and regulatory requirements. A minimum of 2 years of experience in clinical operations or a related field. High school diploma or equivalent is required; an Associate's degree or higher in a related field is preferred. Excellent communication and interpersonal skills. Strong organizational and time management abilities. Attention to detail and accuracy in documentation. The ability to work effectively in a team environment. Proficiency in Microsoft Office Suite and clinical trial management software. A Certified Clinical Research Coordinator (CCRC) or equivalent certification is preferred. Basic Life Support (BLS) certification is required.
Posted 3 weeks ago
2.0 - 7.0 years
3 - 6 Lacs
chennai
Work from Office
Roles & Responsibilities: Core Objective: To handle operations of the center seamlessly Drives the center revenue and achieves target Contributes directly to top line revenue Core Skills: Good oral and written communication skills in Regional Language, English Good people skills, be a Team player - Networking & Relationship Building Personal integrity, ability to deal with sensitive issues with tact, diplomacy and judgment Maintain complete discretion and confidentiality Planning, Organizing, Prioritizing & Time Management skills Personal Grooming, Good Etiquette Ability to handle stress, crisis management & extended working hours. Job description Ensure smooth functioning of all healthcare operations in the assigned hospital. Responsible for day to day operations of the branch focusing on customer service, quality, people management and process adherence. Handling the revenue of the hospital. Ensure smooth functioning of the assigned branch. Tracking branch performance. Focus on patient satisfaction and quality. Credit billing status to be monitored. Pending ALs to submission of bills. Checking of Counsellors reports daily for Advise Vs Converted / Counselled. Conducting Weekly and Monthly reviews with Counselors, Floor managers and PCA. Report to be submitted to Management. Giving On Job training to Counselors, Patient care associates. Random Counseling. Random Patient Calls (Post OP Patients, General Patients, Emergency Cases) Interaction with Doctors about Targets, High Value Cases & Procedures. Co-ordination with Surgeons. Attending to patient Complaints of your zone & speaking to them personally. Prepare monthly tour plan and submit for approval. Daily and monthly report with summary of area with explanation. Define and drive Standard Operating Procedures for service excellence. Please do reach out for any clarification, Akshaya VM - 7708836218 Interested candidates Call/whatsapp - 9176677020 or can share your updated resume to akshaya.vm@dragarwal.com
Posted 3 weeks ago
3.0 - 6.0 years
12 - 18 Lacs
dadri
Work from Office
Responsibilities: * Oversee hospital operations & clinical services * Ensure compliance with medical standards & policies * Collaborate with healthcare teams on patient care strategies * Manage staff performance & development
Posted 3 weeks ago
3.0 - 8.0 years
4 - 7 Lacs
noida, ghaziabad, greater noida
Work from Office
Key Responsibilities: Manage and ensure coordination within medical services to deliver on service quality standards. Monitors clinical and other established indicators to ensure ongoing quality assurance. Responsible for implementation and adherence to SOPs in all Clinical Specialties, conducting regular Medical Audits on an ongoing basis. Strictly adheres to organizations regulations and policies especially those related to infection control, patient safety and JCI/NABH. Ensure that proper Standard Operative Procedures are in place for the efficient care of patients (Admission, care & Discharge). Set up & ensure the regular functioning of clinical/ Nonclinical committees, in consultation with the Medical Superintendent. Supports Continuous Quality Improvement and participates and contributes to all the quality assurance activities of the service To work closely with the Nursing Superintendent and take all necessary steps to ensure high standard of patient care. Responsible for the continuity of care of patient by ensuring that the duty roster is prepared and adhered to by Medical Officers, Technicians and paramedical directly and the nurses through the office of Nursing Superintendent. Participates and contributes in scheduled in-service training programs like ACLS, BLS, CNEs, CMEs, In house activities, conferences or other programs as requested Exercises effective interpersonal skills in dealings with department staff, associates and Management Maintains confidentiality as per the agreement signed. Demonstrates the ability to listen to others in promoting effective communication. Develops thorough understanding of policies and procedures of the hospital and Demonstrates respect for them. To coordinate with the Emergency team for all medico legal cases received at the hospital. To coordinate with Marketing team in organizing medical camps/ CMEs within & outside the hospital To coordinate with HR team in recruiting staff & facilitating Induction To carry out other duties when requested by the Head of department.
Posted 3 weeks ago
3.0 - 8.0 years
0 - 0 Lacs
bangalore, mangalore, anantnag
On-site
Clinical Trial Associate (CTA) provides essential administrative and operational support to clinical trial teams, assisting with tasks related to document management, regulatory compliance, communication, and data management. CTAs play a crucial role in ensuring trials are conducted efficiently and ethically, and in accordance with established guidelines. Here's a more detailed breakdown: Key Responsibilities: Document Management: CTAs are responsible for creating, collecting, organizing, and maintaining essential study documents, including protocols, informed consent forms, case report forms, and study plans. Regulatory Compliance: They ensure all trial-related activities adhere to relevant regulations and guidelines, such as Good Clinical Practice (GCP). Communication: CTAs facilitate communication between the study team, sponsors, and other stakeholders, including investigators, vendors, and regulatory bodies. Administrative Support: They provide general administrative support to the clinical operations department, including scheduling meetings, preparing presentations, and managing travel arrangements. Data Management: CTAs assist with data entry, cleaning, and quality control, ensuring data integrity and accuracy. Study Tracking: They track study progress, maintain study metrics, and generate reports to monitor trial performance. Other Tasks: CTAs may also be involved in tasks such as investigator and third-party payments, site contract management, and management.
Posted 4 weeks ago
2.0 - 6.0 years
0 Lacs
hyderabad, telangana
On-site
Are you ready to become a Clinical Operations Program Manager at Novartis As the Clinical Operations Program Manager, you will oversee and coordinate early modeling viability assessments, global feasibility assessments, recruitment projections, and allocation strategies for assigned trials and programs. Your key responsibilities will include analyzing various data sources such as clinical trial data, historical performance, publications, epidemiology, clinical trial and commercial landscape to provide modeling and viability analysis supporting early recruitment projections and clinical trial planning. You will conduct end-to-end clinical trial feasibility in collaboration with country feasibility managers, clinical trial teams, and medical teams. Additionally, you will propose optimal country and site allocation while considering associated risks and opportunities in alignment with global program strategy. Your role will also involve providing feedback on study design based on available data and feasibility insights. To qualify for this position, you should have a degree in Life Sciences or related scientific discipline, along with approximately 2-3 years of pharmaceutical clinical drug development experience. A solid understanding of all aspects of clinical drug development, particularly clinical trial design and execution, is essential. Demonstrated experience in data-driven feasibility for global clinical trials and the ability to collaborate in a matrix environment are also required. Novartis is committed to reimagining medicine to improve and extend people's lives, with a vision to become the most valued and trusted medicines company globally. By joining Novartis, you will be part of a mission-driven company where our associates are essential in driving us towards our ambitions. To learn more about our purpose and vision, visit our website: https://www.novartis.com/about/strategy/people-and-culture At Novartis, we are dedicated to building an outstanding, inclusive work environment with diverse teams that represent the patients and communities we serve. We are also committed to working with and providing reasonable accommodation to individuals with disabilities. If you require accommodation during the recruitment process or to perform the essential functions of a position, please contact us at [email protected] and include the job requisition number in your message. If you are interested in staying connected with Novartis and learning about future career opportunities, you can join our Novartis Network here: https://talentnetwork.novartis.com/network Join us at Novartis and be part of a community of smart, passionate individuals collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients" lives. Together, we can create a brighter future. Learn more about our commitment to helping people with diseases and their families here: https://www.novartis.com/about/strategy/people-and-culture For detailed information about benefits and rewards at Novartis, please refer to our handbook: https://www.novartis.com/careers/benefits-rewards Division: Development Business Unit: Innovative Medicines Location: India Site: Hyderabad (Office) Company/Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area: Research & Development Job Type: Full-time Employment Type: Regular Shift Work: No Novartis is dedicated to fostering an inclusive work environment and diverse teams, reflecting the patients and communities we serve.,
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. The company is dedicated to transforming innovative science into medical solutions that provide value and hope to patients and their families. By focusing on addressing unmet medical needs and upholding ethics and integrity in business practices, Astellas strives to enhance the health of individuals globally. This particular position is based in Bangalore, India, and emphasizes the significance of work-life balance. Astellas believes in creating an optimal work environment that fosters productivity for all employees, promoting success and achievement. The primary purpose and scope of this role involve supporting the Clinical Trial Lead(s) and Clinical Trial Manager(s) in the day-to-day operations, setup, execution, and closure of designated drug trials. These trials may encompass pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access, and post-marketing regulatory commitment trials, both interventional and non-interventional. The individual in this position is responsible for assisting the clinical trial team in executing trials effectively, collaborating with cross-functional team members and vendors to ensure proper trial processes setup and execution of protocols with operational excellence. It is crucial to adhere to standard operating procedures (SOPs) and guidelines to ensure the quality of trial outcomes. Reporting to the Clinical Operations Functional Manager or Clinical Operations Lead, the key responsibilities and accountabilities of this role include supporting the day-to-day operations of assigned trials, ensuring compliance with project objectives, milestones, and deliverables in accordance with GCP/ICH guidelines and regulatory requirements. Maintaining accurate trial information within tracking systems, contributing to trial plan development, coordinating data cleaning, and participating in site feasibility assessment are integral aspects of the role. The individual is expected to participate in the setup and management of CROs and vendors during trial execution, facilitate TMF setup and maintenance, manage trial documentation, and coordinate investigator and site monitor training. Compliance with regulations, SOPs, and standards throughout trial setup, conduct, and closure is essential. Qualifications for this role include a BA/BS degree or Associates degree with at least 2 years of experience in the healthcare field. Proficiency in interpersonal, written, verbal, presentation, administrative, and computer skills is required, along with fluency in English. General knowledge of drug development and ICH/GCP guidelines is necessary. Minimal travel may be required. Preferred qualifications include an advanced degree. Astellas is committed to ensuring equality of opportunity in all aspects of employment, including Disability/Protected Veterans.,
Posted 1 month ago
8.0 - 12.0 years
0 Lacs
karnataka
On-site
Are you ready to lead and optimize strategic partnerships that drive innovation and efficiency in clinical trials At GSK, we are committed to improving lives through groundbreaking research and development. As a Third-Party Management Senior Director, you will play a pivotal role in fostering strong collaborations with external vendors ensuring efficiency, quality, and compliance. The Third-Party Management Director will oversee and optimize the delivery of services and projects through strategic partnerships with external vendors, contractors, and service providers. This role ensures efficient and effective service delivery, upholds high standards of compliance and quality, and manages supplier risk in partnership with the Global Clinical Operations (GCO) Excellence Team. The Third-Party Management Director will collaborate closely with various stakeholders to ensure robust oversight of third-party vendors at the project level, while driving continuous improvement in operational performance. By fostering strong, value-driven partnerships, this role is critical in maximizing the benefits of third-party engagements and supporting the company's strategic objectives. Key Responsibilities: - Guide, mentor, and support the GCO TA teams by identifying the optimum external support, expertise & technology to deliver our pipeline (i.e. including FSO, DCT). - Set clear performance expectations with the vendors and conduct regular performance reviews for the team. - Monitor TP key performance indicators (KPIs) and drive continuous improvement in trial delivery. - Act as a point of escalation for Third Party issues, including contract negotiations. - Maintaining strong relationships with internal and external stakeholders. - Support the GCO TA teams in defining optimal trial strategies and identifying process improvements for cost-effective trial delivery. - Identify and evaluate tech-enabled solutions to expedite delivery of programs in the assigned therapy area in partnership with the Digital, Analytics & Performance team. - Ensure compliance with FSO handbook, guidelines, GSK SOPs, and GCP, conducting regular lessons learnt and updates. - Promote a culture of safety and continuous improvement within the team. - Lead periodic cross-functional review meetings with CRO partners, analyzing data to identify trends and opportunities for improvement. Basic Qualifications: - Bachelor's degree in a scientific discipline. - Experience in strategic positions requiring strong business acumen within clinical operations. - Expertise in clinical trial delivery and familiarity with decentralized clinical trials (DCT). - Experience managing global teams and stakeholders across diverse geographies. - Leadership experience in a large matrix environment and experience in constructively challenge practices with senior leaders, with the ability to influence and negotiate effectively. - Experience working independently and the ability to quickly build personal credibility and assimilate business issues/need. Preferred Qualifications: - Master's or Doctorate in drug development or a related field. - Knowledge of innovative approaches and technologies in clinical trial management. - Strong influencing and negotiations skills in challenging, ambiguous and/or changing environments. - Strong interpersonal skills and cultural awareness to bridge differences effectively. - Strong verbal, written, and presentation communication skills. - High energy, enthusiasm, and commitment to driving results. Why GSK Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies: GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in gsk.com, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.,
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
malappuram, kerala
On-site
As the Learning and Development Manager at Almas Hospital, Kottakkal, you will play a crucial role in enhancing the skills and knowledge of our clinical and non-clinical staff. Almas Hospital is a renowned multi-specialty healthcare institution known for its commitment to patient care, clinical quality, and professional development. In this role, you will lead the design, implementation, and evaluation of training programs to support the continuous growth and development of our workforce. Your responsibilities will include assessing organizational learning needs, developing structured training programs, and delivering orientation sessions for new joiners, with a specific focus on nurses and clinical staff. You will conduct training on clinical competencies, soft skills, leadership, safety protocols, and policy compliance. Collaborating with department heads, you will identify skill gaps and training requirements to ensure that our staff remains equipped with the necessary knowledge and skills. To excel in this role, you should have a Bachelor's or Master's Degree in Nursing, with additional certifications in Training & Development or Hospital Administration being advantageous. A minimum of 5 years of experience in hospital-based learning & development or nursing education is required. Your deep understanding of clinical operations, hospital workflows, and adult learning principles will be essential in designing effective training programs. Your communication, facilitation, and leadership skills will be instrumental in delivering engaging training sessions and workshops. Proficiency in preparing training content, utilizing digital learning platforms, and ensuring compliance with accreditation standards such as NABH is crucial. You will also be responsible for maintaining training records, coordinating Continuous Nursing Education (CNE) programs, and evaluating the impact of training interventions to drive continuous improvement. If you are passionate about enhancing the skills of healthcare professionals, fostering a culture of continuous learning, and making a positive impact in a dynamic healthcare environment, we invite you to join our team as the Learning and Development Manager at Almas Hospital, Kottakkal. Job Type: Full-time Schedule: - Day shift - Morning shift Experience: - Learning and Development: 2 years (Required) - Healthcare: 2 years (Required) Work Location: In person,
Posted 1 month ago
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