1188 Clinical Research Jobs - Page 17

Job location: Kolkata YOUR TASKS AND RESPONSIBILITIES: Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts Preparation and submission of study documents for EC permission for respective study across centers Oversee & document IP dispensing, inventory management & reconciliation Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated Investigator and site personnel training on the Study protocol, procedures, and GCP principles Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL WHO YOU ARE: Minimum qualification requirement is to have a Bachelors or Masters degree in a health[1]related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Relevant experience of 1-5 years minimum in the field of Clinical Research

Job Location: Pune YOUR TASKS AND RESPONSIBILITIES: Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts Preparation and submission of study documents for EC permission for respective study across centers Oversee & document IP dispensing, inventory management & reconciliation Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated Investigator and site personnel training on the Study protocol, procedures, and GCP principles Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL WHO YOU ARE: Minimum qualification requirement is to have a Bachelors or Masters degree in a health[1]related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Relevant experience of 1-5 years minimum in the field of Clinical Research

YOUR TASKS AND RESPONSIBILITIES: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspection/audit readiness. This role will be responsible for establishing the procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures. Systems and Processes: Develop, implement and maintain a Quality Management System (QMS) for clinical trial team in consultation with Head Quality Compliance & Training and ensure oversight on team on quality aspect as per defined SOPs and applicable regulations. Implement and oversee the Quality Compliance procedures/processes/systems for clinical trials managed by the Medical science and Clinical Operations department. To assist in designing a process to write, review and approve the risk assessments for new trials and for ongoing projects and working closely with Project Managers and Operation Head as needed. To ensure a process in place to provide assurance on review of all study documentation for accuracy, consistency and completeness. Ensure effective systems and processes in place to maintain consistency and quality compliance parameters in medical science, operations, data management and drug depot for end-to-end activities of each function as per applicable regulatory requirements. Work with Clinical Research QC team, Medical Science team, Clinical Operations team, Clinical Data Management team and Study Management team to create and implement study specific QC plans that outline the scope of Quality Compliance procedures to be followed during clinical trials, ensuring QC processes are in alignment with SOPs and study protocols. Ensure completeness of training of study team on SOPs and job specific training as per role and responsibilities. Ensure periodic review of training files for all study team. Assess and identify the training requirement of study team and ensure completion of training. Well versed with electronic systems used in Clinical Trial operations, Data Management and Project Management which includes project specific deliverables tracking and important milestone related alarms, protocol compliance tracking, deviations tracking and electronic systems used for managing Trial Master File (TMF) and Drug accountability. Assist in developing system/process to work with the clinical trial team to schedule pre-execution and post-execution QC activities to ensure that all requirements of the QC plans are planned as required and executed. Plan, design, and update process and systems for clinical trial activities like development and utilization of QC assessment parameters and other QC tools designed to document/track the QC review process for clinical research activities in line with recent regulatory requirement. Ensure Quality Management System at Medical Science, Data Management team, Operation team to ensure the department is ready for audit/inspection 24x7. Ensure periodic review of Vendors and renewals as per applicable policies & procedures. Identify and recommend process improvement initiatives where required. Create and evaluate metrics to assess performance and implement plans for course correction. Activities: Should be effective team player who can work closely with different study teams and collaborate well with team members to achieve defined QC targets. Develop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices. Identify and decide team members job specific SOP training requirements in view of their role and maintain oversight of training to ensure all team members are trained on each SOP as required. Preparation of SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team. Quality review of the clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement. Quality review of the clinical trial operation related activities, related tools, plans and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring site specific reports, Site Documents, logs and close out activities in line with ICH GCP requirement, Indian and global regulatory requirement. Ensure Quality review of SOPs and oversight on quality parameters specific to Clinical Trial Supply Management (CTSM) and other activities like receipt, handling of study sample, labelling, storage, temperature monitoring systems and distribution to trial sites. Final QC review of study close out activities including returned goods reconciliation, inventory destruction processing and archiving of documents. Review and communication of QC findings to respective department in stipulated timelines. Arrange monthly meeting or meetings as and when required depending on criticality of the issues with concerned team to discuss and communicate the findings from QC reviews to the internal stakeholders via QC summaries, reports as required. Maintain the repository of QC findings as per the department and specific function and present the trend analysis, training requirement and action plan with timelines to Head Medical Affairs and clinical for course correction on quarterly basis. Ensure training of SOPs, on job training and reviewing training files on regular basis. QC review and Support in preparation of clinical study manuals/documents/Plan such as the IMP handling manual, Study plans. Ensure record maintenance for all activities for traceability in line with regulatory requirement. WHO YOU ARE: > 5 years experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department. Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills. Must have experience in handling audits & inspections of DCGI, US FDA. Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials. Experience of working in matrix business environments preferred. Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards. Quality oriented mindset and skill set. Experience in auditing processes and procedures, including the development of plans for corrective and preventive action (CAPA). In-depth working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical research. Proactive approach to reviewing, updating and improving processes based on current knowledge of the regulatory requirements. Have strong analytical and problem-solving skills and the ability to present solutions. Able to work under pressure and prioritize workload effectively, able to ensure timely completion of tasks to high quality in a matrix organization. Eye for details, Sense of urgency & desire to excel. Proficiency with Excel or other quality management systems/ tools. Result oriented and performance driven. Excellent interpersonal & communication skills to effectively interact with a broad range of audience. Job location: Sun House, Goregaon East, Mumbai

Cognitio Analytics LLC is looking for Sr. Medical Coding Consultant to join our dynamic team and embark on a rewarding career journey. Undertake short-term or long-term projects to address a variety of issues and needs Meet with management or appropriate staff to understand their requirements Use interviews, surveys etc. to collect necessary data Conduct situational and data analysis to identify and understand a problem or issue Present and explain findings to appropriate executives Provide advice or suggestions for improvement according to objectives Formulate plans to implement recommendations and overcome objections Arrange for or provide training to people affected by change Evaluate the situation periodically and make adjustments when needed Replenish knowledge of industry, products and field

Bhagwan Mahaveer Cancer Hospital & Research Centre is looking for Senior Resident Radiation Oncology to join our dynamic team and embark on a rewarding career journey. Patient Care: Provide comprehensive medical care to patients under the supervision of attending physicians Perform physical examinations, diagnose medical conditions, develop treatment plans, and monitor patient progress Clinical Supervision: Supervise and provide guidance to junior residents, interns, and medical students in their clinical duties Assist in their training, evaluation, and professional development Hospital Rounds: Conduct regular hospital rounds to assess patients, review test results, and discuss treatment plans with the healthcare team Coordinate and communicate patient care plans with nurses, specialists, and other healthcare professionals Medical Procedures: Perform or assist in various medical procedures, such as venipuncture, wound care, suturing, and bedside procedures Ensure adherence to sterile techniques, safety protocols, and best practices Medical Documentation: Maintain accurate and up-to-date medical records, including patient history, physical examination findings, treatment plans, and progress notes Ensure compliance with legal and regulatory requirements Patient Education: Educate patients and their families about their medical conditions, treatment options, and preventive measures Provide counseling on lifestyle modifications, medication management, and post-discharge care instructions Interdisciplinary Collaboration: Collaborate with other healthcare professionals, including nurses, pharmacists, therapists, and social workers, to ensure coordinated and holistic patient care Participate in interdisciplinary team meetings and contribute to care planning Continuity of Care: Facilitate smooth transitions of care between inpatient and outpatient settings Coordinate follow-up appointments, referrals, and discharge planning to ensure continuity of care and optimal patient outcomes Medical Research and Education: Stay updated with the latest medical advancements, evidence-based practices, and clinical guidelines Engage in research activities, present at conferences, and contribute to medical education and scholarly activities Quality Improvement: Participate in quality improvement initiatives to enhance patient safety, clinical outcomes, and healthcare delivery Identify areas for improvement, implement evidence-based practices, and contribute to quality assurance programs Professional Development: Engage in continuing medical education (CME) activities, attend conferences, and pursue opportunities for professional growth Maintain licensure and board certification requirements

ob Overview Assists with the design/development of software solutions requiring general domain knowledge and limited business expertise. Troubleshoots code issues and continuously evolves IQVIAs platforms to meet user requirements/needs. Essential Functions Assists with the design/development of software solutions requiring general domain knowledge and limited business experience. Works at all layers of the application stack including front-end user interface and backend development. Troubleshoots code issues and evolves IQVIAs platforms to meet user requirements/needs. Participates in the review of functional specifications and other validation deliverables as assigned. Develops an introductory understanding of industry and IQVIA-specific quality standards. Supports small development projects based on specific instructions and with limited discretion. Typically requires no prior relevant experience. Qualifications Bachelors Degree Computer Science of Engineering or equivalent in experience Req Experience in object-oriented languages like Java, PHP, Ruby, or Python and the fundamental principles of object-oriented principles. Experience in website development with HTML, CSS and JavaScript. React and NodeJS experience is a bonus. Understanding of relational databases and experience with basic SQL queries desired but not required. . 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

HEOR analyst role that contributes to the generation of insights and solutions into ways of improving real-world patient outcomes. Role is focused on projects that will impact decision-making in various health care systems on treatment innovations, care provision and access. Essential Functions Produce materials and services relating to the Health Economics Outcomes Research business areas (health economic modelling, evidence synthesis, statistical analysis, health technology assessment submissions, report and publication development for value communication) that generate value for our clients Engage with large data sets and apply real-world data to health economic decision-support tools Develop your project management skills through client liaison and collaboration with senior project managers Contribute to business development as we'll as internal initiatives for the advancement of innovative methodological approaches Work closely with a diverse range of peers, project managers Qualifications A degree in science, economics, mathematics, statistics, computer science or another relevant discipline. Strong numeracy and quantitative skills as we'll as competency using MS Excel and statistical packages (eg, Stata, R, SAS) Capable of tackling loosely defined problems analytically and applying pragmatic and logical problem-solving skills. Communicative person that values building strong relationships with colleagues and clients and have the ability to explain complex topics in simple terms and in a structured way, both spoken and written.

"Job Description: We are seeking a highly motivated and detail-oriented Research Ops Intern- Clinical Data to join our dynamic team. The ideal candidate will have a strong background in oncology, the ability to understand and interpret medical terminology from Electronic Health Records (EHR) and medical reports, and the expertise to extract and analyze data from patient notes. The candidate must have a background of clinical research and is able to comprehend clinical trials. Also have good knowledge about patient pre-screening, enrolling participants in oncology clinical trials . The role requires proficiency in Google Sheets and Excel, along with the ability to correlate medical data to meet specific requirements. Duration: 3 months Key Responsibilities: Clinical Trials Acumen: Interpret the Inclusion and Exclusion criteria outlined in the clinical trials on clinicaltrials.gov and in study protocols, and use this information to assess patient eligibility for clinical trials. Data Extraction and Curation: Extract relevant data from patient notes, EHRs, patient information, medical history, laboratory/pathology results, diagnoses, and treatments, to support oncology research and clinical decision-making. Medical Terminology: Interpret and understand complex medical terms, especially those related to oncology to ensure accurate data extraction and analysis. Data Management: Maintain and manage datasets using Google Sheets and Excel, ensuring data accuracy and integrity. Correlation and Interpretation: Analyze medical data to identify patterns and correlations that align with project requirements. Quality Assurance: Conduct regular quality checks and validation of extracted data to ensure consistency and accuracy. Patients Pre-screening: Knowledge of pre-screening patients before enrolling to clinical trials would be required to curate and verify clinical trials on the companys platform Qualifications: Bachelors/Masters degree in a relevant field such as Clinical Research, Health Information Management, Medical Informatics, Oncology, or a related discipline. 6 months of experience in clinical research/oncology research/clinical data abstraction/clinical data curation. Candidates with Clinical Trial Certification will be preferred. Proficiency in Google Sheets and Excel; familiarity with data extraction tools and EHR systems. Strong understanding of oncology, medical, and pathology terminologies. Excellent analytical and problem-solving abilities, with a keen eye for detail. Strong written and verbal communication skills, with the ability to present complex data in a clear and concise manner. Ability to manage multiple tasks and projects simultaneously, with strong organizational and time-management skills. Ability to work effectively both independently and as part of a multidisciplinary team."

"Job Description: We are seeking a highly motivated and detail-oriented Research Ops Intern- Clinical Data to join our dynamic team. The ideal candidate will have a strong background in oncology, the ability to understand and interpret medical terminology from Electronic Health Records (EHR) and medical reports, and the expertise to extract and analyze data from patient notes. The candidate must have a background of clinical research and is able to comprehend clinical trials. Also have good knowledge about patient pre-screening, enrolling participants in oncology clinical trials . The role requires proficiency in Google Sheets and Excel, along with the ability to correlate medical data to meet specific requirements. Duration: 3 months Key Responsibilities: Clinical Trials Acumen: Interpret the Inclusion and Exclusion criteria outlined in the clinical trials on clinicaltrials.gov and in study protocols, and use this information to assess patient eligibility for clinical trials. Data Extraction and Curation: Extract relevant data from patient notes, EHRs, patient information, medical history, laboratory/pathology results, diagnoses, and treatments, to support oncology research and clinical decision-making. Medical Terminology: Interpret and understand complex medical terms, especially those related to oncology to ensure accurate data extraction and analysis. Data Management: Maintain and manage datasets using Google Sheets and Excel, ensuring data accuracy and integrity. Correlation and Interpretation: Analyze medical data to identify patterns and correlations that align with project requirements. Quality Assurance: Conduct regular quality checks and validation of extracted data to ensure consistency and accuracy. Patients Pre-screening: Knowledge of pre-screening patients before enrolling to clinical trials would be required to curate and verify clinical trials on the companys platform Qualifications: Bachelors/Masters degree in a relevant field such as Clinical Research, Health Information Management, Medical Informatics, Oncology, or a related discipline. 6 months of experience in clinical research/oncology research/clinical data abstraction/clinical data curation. Candidates with Clinical Trial Certification will be preferred. Proficiency in Google Sheets and Excel; familiarity with data extraction tools and EHR systems. Strong understanding of oncology, medical, and pathology terminologies. Excellent analytical and problem-solving abilities, with a keen eye for detail. Strong written and verbal communication skills, with the ability to present complex data in a clear and concise manner. Ability to manage multiple tasks and projects simultaneously, with strong organizational and time-management skills. Ability to work effectively both independently and as part of a multidisciplinary team."

"Job Description: We are seeking a highly motivated and detail-oriented Research Ops Intern- Clinical Data to join our dynamic team. The ideal candidate will have a strong background in oncology, the ability to understand and interpret medical terminology from Electronic Health Records (EHR) and medical reports, and the expertise to extract and analyze data from patient notes. The candidate must have a background of clinical research and is able to comprehend clinical trials. Also have good knowledge about patient pre-screening, enrolling participants in oncology clinical trials . The role requires proficiency in Google Sheets and Excel, along with the ability to correlate medical data to meet specific requirements. Duration: 3 months Key Responsibilities: Clinical Trials Acumen: Interpret the Inclusion and Exclusion criteria outlined in the clinical trials on clinicaltrials.gov and in study protocols, and use this information to assess patient eligibility for clinical trials. Data Extraction and Curation: Extract relevant data from patient notes, EHRs, patient information, medical history, laboratory/pathology results, diagnoses, and treatments, to support oncology research and clinical decision-making. Medical Terminology: Interpret and understand complex medical terms, especially those related to oncology to ensure accurate data extraction and analysis. Data Management: Maintain and manage datasets using Google Sheets and Excel, ensuring data accuracy and integrity. Correlation and Interpretation: Analyze medical data to identify patterns and correlations that align with project requirements. Quality Assurance: Conduct regular quality checks and validation of extracted data to ensure consistency and accuracy. Patients Pre-screening: Knowledge of pre-screening patients before enrolling to clinical trials would be required to curate and verify clinical trials on the companys platform Qualifications: Bachelors/Masters degree in a relevant field such as Clinical Research, Health Information Management, Medical Informatics, Oncology, or a related discipline. 6 months of experience in clinical research/oncology research/clinical data abstraction/clinical data curation. Candidates with Clinical Trial Certification will be preferred. Proficiency in Google Sheets and Excel; familiarity with data extraction tools and EHR systems. Strong understanding of oncology, medical, and pathology terminologies. Excellent analytical and problem-solving abilities, with a keen eye for detail. Strong written and verbal communication skills, with the ability to present complex data in a clear and concise manner. Ability to manage multiple tasks and projects simultaneously, with strong organizational and time-management skills. Ability to work effectively both independently and as part of a multidisciplinary team."

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Physiotheraphy Years of Experience: 0 to 1 years 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 You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create 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 Junior Drug Safety AssociateJunior Drug Safety Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Physiotheraphy

Responsible for maintaining the product backlog change items, Prioritising the items as per the business need and maintain open communication with all the partners. Perform functional analysis of customer’s requirements and understand how insurance products will be integrated with proposed solution through collaborating with customer’s resources/requirements, workshop sessions. Perform impact analysis of the changes requested on the product functions and provide detailed analysis to evaluate the extend of changes, impacted areas of the system, Document the impact, provide walk-throughs and obtain sign-offs from the customer Facilitate/manage design sessions regarding business functionality and/or product logic with the customer. Ability to communicate and influence the Business/Design teams to achieve the Business benefit as per the agreed priorities of the requirement Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise Education Qualification - BE/Btech/MCA/M.Tech, 6-7 yrs Experience in Advises clients regarding products & solutions for solving problems in the Insurance Industry. Experience in Insurance industry and deep knowledge of clients' businesses and how it relates to specific Insurance segments. knowledgeable in the trends and directions of the industry, the marketplace, and the players. Respond to technical queries / requests from team members and customers Preferred technical and professional experience Ambitious individual who can work under their own direction towards agreed targets/goals. Ability to handle change and be open to it along with good time management and an able to work under stress Proven interpersonal skills while contributing to team effort by accomplishing related results as needed

Narayana Nethralaya is looking for Consultant Physician to join our dynamic team and embark on a rewarding career journey Consultant PhysicianDiagnose medical conditions Provide patient care Monitor treatment plans Collaborate with healthcare teams

YOUR TASKS AND RESPONSIBILITIES: Core scientific member of cross-functional franchise team and a disease area expert, responsible for scientific enablement of respective business cluster Conceptualization and project management of wide range of medical activities that are aligned to the respective franchise strategy like: New Product Ideation New Product Evaluation Therapeutic rationale relevant Medical support for regulatory submissions Preparation of SEC presentations defense in SEC meeting Pre-launch launch preparations including product monograph, training manuals, training CME slides Franchise Medical Education programs Promotional and non-promotional material review approval Answering queries Marketing and Sales training Real World Clinical Research and Publications - Planning and Execution Advisory board meetings Developing Insight driven Medical Plans Interaction Engagement of identified Key Opinion leaders in a peer-to-peer capacity through medical affairs activities, in alignment with the overall strategic plan to shape disease areas of interest A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, obtain insights into patients treatment trends and insights in the disease areas of interest and to be considered a trusted scientific counterpart Responsible for identifying knowledge gaps, practice gaps and data gaps and provide recommendations for devising medical product education programs, evidence generation and special projects Ability to convert insights on disease trends and treatment patterns from KOLs into viable and formidable solutions to shape the therapeutic areas of interest Devise optimal training plan to ensure flow of latest medical developments in the given to sales marketing team Jointly responsible with marketing teams to support optimal patient outcomes through communication of data, information, and insights to shape disease areas of interest Represent the organization in various internal external scientific platforms Collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute Receiving and processing scientific information requests received from physicians internal stakeholders Ability to handle complex questions from health care professionals related to company products or disease area to satisfaction Responsible for ensuring that all promotional materials are approved within stipulated timelines and in alignment with company approval process Conduct of robust medical evaluation of new products through thorough desk research and interactions with KOLs WHO YOU ARE: Education: MD (Pharmacology) Experience: 3+ years working experience in the pharmaceutical industry or research company in a capacity of HO Medical Advisor or Sr. Medical Advisor Training in medical writing, clinical trial methodologies, research design and ICH - GCP will be added advantage Must have working knowledge of Indian regulations pertaining to Health care professionals interactions (MCI code of ethics for doctors UCPMP Code for Pharma) and Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Strategic mindset with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer capacity Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and award Job Location: Sun House, Goregaon East, Mumbai

YOUR TASKS AND RESPONSIBILITIES: Core scientific member of cross-functional franchise team and a disease area expert, responsible for scientific enablement of respective business cluster Conceptualization and project management of wide range of medical activities that are aligned to the respective franchise strategy like: New Product Ideation New Product Evaluation Therapeutic rationale relevant Medical support for regulatory submissions Preparation of SEC presentations defense in SEC meeting Pre-launch launch preparations including product monograph, training manuals, training CME slides Franchise Medical Education programs Promotional and non-promotional material review approval Answering queries Marketing and Sales training Real World Clinical Research and Publications - Planning and Execution Advisory board meetings Developing Insight driven Medical Plans Interaction Engagement of identified Key Opinion leaders in a peer-to-peer capacity through medical affairs activities, in alignment with the overall strategic plan to shape disease areas of interest A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, obtain insights into patients treatment trends and insights in the disease areas of interest and to be considered a trusted scientific counterpart Responsible for identifying knowledge gaps, practice gaps and data gaps and provide recommendations for devising medical product education programs, evidence generation and special projects Ability to convert insights on disease trends and treatment patterns from KOLs into viable and formidable solutions to shape the therapeutic areas of interest Devise optimal training plan to ensure flow of latest medical developments in the given to sales marketing team Jointly responsible with marketing teams to support optimal patient outcomes through communication of data, information, and insights to shape disease areas of interest Represent the organization in various internal external scientific platforms Collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute Receiving and processing scientific information requests received from physicians internal stakeholders Ability to handle complex questions from health care professionals related to company products or disease area to satisfaction Responsible for ensuring that all promotional materials are approved within stipulated timelines and in alignment with company approval process Conduct of robust medical evaluation of new products through thorough desk research and interactions with KOLs WHO YOU ARE: Education: MD (Pharmacology) Experience: 3+ years working experience in the pharmaceutical industry or research company in a capacity of HO Medical Advisor or Sr. Medical Advisor Training in medical writing, clinical trial methodologies, research design and ICH - GCP will be added advantage Must have working knowledge of Indian regulations pertaining to Health care professionals interactions (MCI code of ethics for doctors UCPMP Code for Pharma) and Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Strategic mindset with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer capacity Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and award Job Location: Sun House, Goregaon East, Mumbai

Job Summary: This role will responsible for preparation of clinical high-quality protocol, investigator brochures, regulatory documents, data review, clinical study report, publications, and related clinical documents. Manuscript writing, poster/abstract preparation for conferences, co-ordinate with vendors for out-sourced activities and assist for procurement of scales. YOUR TASKS AND RESPONSIBILITIES: Systems and Processes: Ensure to follow all clinical and regulatory guidelines, processes and systems for medical science activities and ensure compliance to internal medical writing SOPs for Clinical trial To follow the designed process to write, review protocol for new trials and work closely with operation team to ensure high quality operationally feasible protocol for clinical trial To co-ordinate with a process for review of all study synopsis from clinical, regulatory and operational perspective Prepare and review SOPs specific for medical writing for clinical trial Work closely with medical monitors for review of study documents (such as statistical analysis plan, data monitoring plan, coding plan, CRF) and data review activities Identify, recommend and lead process improvement initiatives Create and evaluate metrics to assess performance and implement plans for course correction Well versed with systems (MedDRA and WHO-DD) for data coding including coding of adverse events and drugs Good knowledge of different randomization procedures and different blinding techniques to be used in clinical trials Identify, recommend and lead process improvement initiatives Create and evaluate metrics to assess performance and implement plans for course correction. Activities: Responsible for clinical trial medical science related activities like preparation of protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement Conduct relevant literature search for required for protocol, CSR, and manuscript writing Responsible for writing clinical journal manuscripts, clinical journal abstracts, and study article for publication Responsible for preparation of protocol and clinical study reports presentation in subject s expert committee (SEC) regulatory meeting Responsible for collaboration with vendors for manuscript writing, abstract/poster preparation, procurement of clinical scales/PROs (Patient reported Outcomes) Responsible for coordination with data management team to ensure timely review of data extract and data cleaning activities to ensure timely database lock and release of tables, figures, and listings (TLFs) Responsible for coordinating with biostatistician to engage early with the study team for sample size certificate, review of statistical analysis plan (SAP) apart from review of mock and/or blinded tables, figures, and listings (TFLs), and narrative and discussion planning for relevant documents in co-ordination with medical monitor Responsible for registering on clinical trials registries (e. g. CTRI) Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables Responsible for mentoring and leads less experienced medical writers on complex projects, as necessary WHO YOU ARE: B. Pharma/M. Sc/M. Pharma/PhD/BAMS/BHMS/life sciences educational background 0-1 years of relevant medical writing experience Excellent medical writing skills Well versed with different guidelines such as IMRAD, CONSORT and different publication guidelines Well versed with different guidelines such as IMRaD, CONSORT and relevent publication guidelines Well versed with current GCP/GDP regulations Thorough knowledge of GCP guidelines, ICMR guidelines 2017 and Drugs and Cosmetic Act regulations pertaining to clinical trials and other regulatory guidelines like FDA Experience of working in matrix business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards Strong medical knowledge of different therapeutic area Sound functional knowledge of clinical research and medical writing activities Collaboration and teaming with ability to work in a matrix environment Strategic thinking sound analytical skills Good writing and communication skills Sense of urgency desire to excel Proficiency with Excel or software statistical tools. Self-awareness and adaptability to work in a matrix environment Result oriented and performance driven Excellent interpersonal communication skills to effectively interact with a broad range of audience Job location: Sun House, Goregaon East, Mumbai

Provide advanced technical expertise to develop and maintain programs to meet internal and external clients needs. Plan and lead the development of project-related solutions to the full scope of statistical programming tasks. Provide technical expertise to the Statistical Programming department. Essential Functions Perform and plan: (i) the programming, testing, and documentation of programs for use in creating statistical tables, figures and listing summaries, (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients. May perform and plan the programming of database quality control checks. Program the integration of databases from multiple studies or sources. Develop programming documentation including plans and specifications, as appropriate. Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to teams and department. Perform and plan the development, implementation and validation of new process technologies, macros and applications. Fulfill project responsibilities at the level of statistical team lead for single studies, under supervision. Understand the Scope of Work, estimate the work completed, and manage Out of Scope for single studies. May manage budget and resource requirements and provide revenue and resource forecasts for single studies. May be required to understand budget and quote assumptions. Provide training and guidance to lower level and new staff. Qualifications Masters Degree Computer science or related field and 4 year relevant experience Req Or Bachelors Degree Computer science or related field and 5 years relevant experience Req Equivalent combination of education, training and experience Req Knowledge of statistics, programming and/or clinical drug development process Working knowledge of computing applications such as Base SAS, SAS/STAT and SAS Macro Language Good organizational, interpersonal, leadership and communication skills Ability to effectively handle multiple tasks and projects Excellent accuracy and attention to detail Ability to establish and maintain effective working relationships with coworkers, managers and clients

Financial Accountant II (Finance transformation)- Chennai ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development The Financial Accountant II will work with the wider finance team and finance leadership team in driving the Group s integration and transformation objectives. This role will be key to working within the finance transformation team in identifying and supporting continuous improvement in policies and procedures across the accounting/financial reporting/business partnering group processes. This is an exciting opportunity for an ambitious Finance Accountant to join ICON s experienced and highly motivated finance team at an exciting time for the organization. The individual will play a key role in leading change across the finance organization and delivering key strategic alignment transformation projects. What you will be doing: Supporting finance leadership in the development, implementation and continuous improvement of systems, initiatives and processes. Collaboration within the wider finance organization in the integration of acquisition targets into the group finance structure. Working with interdisciplinary teams to develop and implement group strategy and projects (finance, IT, legal, tax, treasury, HR). Supporting project management of significant change projects across all key finance disciplines. Supporting effective communication across finance in respect of key change projects. Preferably proficient in operating in and leading a strong SOX control environment and providing guidance and direction to the wider group finance team for continuous improvement. Your Profile: Strong communication and project management skills Aptitude or experience in finance process optimisation, automation and systems integrations an advantage. Experience in a range of finance disciplines including e.g. systems change, best practice reporting, P2P, order to cash and treasury processes. An aptitude to identify and lead development, implementation and continuous improvement of projects systems, initiatives and processes. A confident, decisive person with strong interpersonal skills An accomplished professional who is tenacious and determined An experienced high performing ACA, ACCA with minimum 2-4 years PQE Experience in PowerBI and other Business Intelligence tools would be an advantage. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Imaging Support Specialist _ Office Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking an Imaging Support Specialist to join our diverse and dynamic team. As an Imaging Support Specialist at ICON, you will play a vital role in providing technical support and assistance for imaging operations within clinical trials. You will ensure that imaging processes run smoothly, facilitating effective communication and coordination among teams and stakeholders. What You Will Be Doing: Providing day-to-day technical support for imaging systems and processes, troubleshooting issues as they arise. Assisting in the setup and maintenance of imaging equipment, ensuring compliance with safety and regulatory standards. Collaborating with clinical teams to ensure proper execution of imaging protocols and adherence to study timelines. Training staff on imaging procedures, software, and best practices to optimize workflow and data quality. Maintaining accurate records of imaging data, system performance, and support requests to facilitate continuous improvement. Your Profile: Bachelor s degree in medical imaging, radiologic technology, or a related field; relevant certifications preferred. 1-3 years of experience in imaging support or a related role, ideally within a clinical research setting. Strong technical skills and familiarity with imaging equipment and software. Excellent problem-solving abilities, with attention to detail and a proactive approach to support. Strong communication and interpersonal skills, with the ability to work effectively in a team-oriented environment. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Imaging Support Specialist _ Office Based We are currently seeking an Imaging Support Specialist to join our diverse and dynamic team. As an Imaging Support Specialist at ICON, you will play a vital role in providing technical support and assistance for imaging operations within clinical trials. You will ensure that imaging processes run smoothly, facilitating effective communication and coordination among teams and stakeholders. What You Will Be Doing: Providing day-to-day technical support for imaging systems and processes, troubleshooting issues as they arise. Assisting in the setup and maintenance of imaging equipment, ensuring compliance with safety and regulatory standards. Collaborating with clinical teams to ensure proper execution of imaging protocols and adherence to study timelines. Training staff on imaging procedures, software, and best practices to optimize workflow and data quality. Maintaining accurate records of imaging data, system performance, and support requests to facilitate continuous improvement. Your Profile: Bachelor s degree in medical imaging, radiologic technology, or a related field; relevant certifications preferred. 1-3 years of experience in imaging support or a related role, ideally within a clinical research setting. Strong technical skills and familiarity with imaging equipment and software. Excellent problem-solving abilities, with attention to detail and a proactive approach to support. Strong communication and interpersonal skills, with the ability to work effectively in a team-oriented environment. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Financial Accountant II (Finance transformation)- Chennai The Financial Accountant II will work with the wider finance team and finance leadership team in driving the Group s integration and transformation objectives. This role will be key to working within the finance transformation team in identifying and supporting continuous improvement in policies and procedures across the accounting/financial reporting/business partnering group processes. This is an exciting opportunity for an ambitious Finance Accountant to join ICON s experienced and highly motivated finance team at an exciting time for the organization. The individual will play a key role in leading change across the finance organization and delivering key strategic alignment transformation projects. What you will be doing: Supporting finance leadership in the development, implementation and continuous improvement of systems, initiatives and processes. Collaboration within the wider finance organization in the integration of acquisition targets into the group finance structure. Working with interdisciplinary teams to develop and implement group strategy and projects (finance, IT, legal, tax, treasury, HR). Supporting project management of significant change projects across all key finance disciplines. Supporting effective communication across finance in respect of key change projects. Preferably proficient in operating in and leading a strong SOX control environment and providing guidance and direction to the wider group finance team for continuous improvement. Your Profile: Strong communication and project management skills Aptitude or experience in finance process optimisation, automation and systems integrations an advantage. Experience in a range of finance disciplines including e.g. systems change, best practice reporting, P2P, order to cash and treasury processes. An aptitude to identify and lead development, implementation and continuous improvement of projects systems, initiatives and processes. A confident, decisive person with strong interpersonal skills An accomplished professional who is tenacious and determined An experienced high performing ACA, ACCA with minimum 2-4 years PQE Experience in PowerBI and other Business Intelligence tools would be an advantage. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Deliver NoPerformance ParameterMeasure1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback2Self- ManagementProductivity, efficiency, absenteeism, Training Hours, No of technical training completed Mandatory Skills: Pharmacovigilance & Drug Safety(Pharma).

KASHI INSTITUTE OF TECHNOLOGY is looking for Senior Research Assistant (SRA) / Research Assistant ( RA) to join our dynamic team and embark on a rewarding career journey Conduct Research: Design and execute experiments or research projects under the guidance of senior researchers or project leaders. Collect, analyze, and interpret data using various research methodologies and tools. Literature Review: Review relevant literature to understand the current state of knowledge in the research area. Stay updated on advancements in the field and incorporate relevant findings into ongoing research. Data Collection and Analysis: Utilize appropriate techniques to gather data, whether through experiments, surveys, interviews, or other methods. Analyze and interpret data using statistical methods or other relevant analytical approaches. Report Writing: Prepare detailed reports summarizing research findings, methodologies, and conclusions. Contribute to the writing of research papers, articles, and presentations for conferences or publications. Collaboration: Work closely with team members, senior researchers, and other stakeholders to achieve research goals. Participate in research meetings, seminars, and conferences. Equipment and Lab Maintenance: Maintain and operate laboratory equipment as needed. Ensure proper documentation and organization of research materials. Compliance and Ethics: Adhere to ethical guidelines and standards in research activities. Ensure compliance with relevant regulations and protocols.

Responsible for developing the cell based assays and conduct routine screening. Expert knowledge/skill sets in cell culture, biochemical and cell based assays, animal tissue samples. Analytical techniques : Cell culture, ELISA, flow-cytometry, Confocal microscopy, animal Industry - Pharma / Biotech / Clinical Research Functional Area - RD, Pharmaceuticals, Biotechnology Role Category - Research Scientist Desired Profile PG - M.Sc - Bio-Chemistry, Microbiology, M.Tech - Bio-Chemistry / Bio- Technology.

Job DescriptionJob Description Are you looking for a meaningful and fulfilling career in Project Management within the Clinical Research industry? Join Clario's Medical Imaging team in Bengaluru, India, and be part of a legacy with over 30 years of expertise. We specialize in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have ambitious goals and a clear vision for the future. This is your chance to be part of our journey as a Clinical Project Manager. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What you'll 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 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 Medical Imaging 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 At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials. Clario is committed to providing an inclusive workplace that welcomes diversity and equal opportunity. We encourage all qualified candidates who are passionate about sustainability, ethical business, and making a positive impact to apply for this role.