622 Clinical Trials Jobs - Page 25

Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics and APIs, comprising Solid Dosage Formulations and Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research and Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it's a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R and D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL's full-fledged Regulatory Affairs and IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization.

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Reviewer Mumbai (Job Code # 47) b) For Position in Pune Search : Medical Reviewer Pune (Job Code # 48) c) For Position in Bangalore Search : Medical Reviewer Bangalore (Job Code # 51)

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will responsible for managing and maintaining laboratory reference ranges in the Electronic Data Capture (EDC) system. This role involves providing subject matter expert advice on laboratory data, reviewing local and central laboratory reference range documents, creating lab IDs, and entering the ranges and units for each analyst into the EDC system. This individual also identifies and helps resolve discrepancies in local laboratory reference ranges. Roles & Responsibilities: Approve new lab parameters, new units, and textbook ranges. Provide subject matter expert advice on laboratory data. Review local and central laboratory reference range documents. Create lab IDs and enter the ranges and units for each analyst into the EDC system. Identify and help resolve discrepancies in local laboratory reference ranges. Communicate and call out day-to-day issues and risks regarding the area of work. Participate in DM and cross-functional working groups. Promote and advocate for data management best practices internally and externally. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications. Basic Qualifications: Master’s degree and 1 to 3 years of life science, computer science, business administration or related discipline or equivalent experience OR Bachelor’s degree and 3 to 5 years of life science, computer science, business administration or related discipline or equivalent experience OR Diploma and 7 to 9 years of [life science, computer science, business administration or related discipline or equivalent experience. 2-4 years of related experience in clinical data management or laboratory coordination. Must-Have Skills: Strong understanding of laboratory data and clinical reference ranges. Knowledge of Good Clinical Practice Understanding of clinical data management processes Understanding of International laboratory unit standards such as the International System of Units (SI) Understanding of concept of conversion factors and comparable results Good-to-Have Skills: Familiarity with electronic data capture (EDC) systems and data management plans (DMP). Understanding of Electronic Health Record (EMR) Systems Understanding of Laboratory Certification Understanding of Laboratory Equipment Calibration Soft Skills: Excellent communication and collaboration skills. Detail-oriented with strong analytical and problem-solving abilities. Ability to work independently and as part of a team. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions in the Regulatory and Clinical Trial submission product team that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers supporting applications like docuBridge Suite from Lorenz and Disclose from Citeline, developing scalable solutions, automating operations, monitoring system health, and responding to incidents to minimize downtime. The ideal candidate will have a strong background in regulatory submissions and clinical trials, along with innovative and transformational experience. Roles & Responsibilities: Take ownership of complex software projects from conception to deployment Manage software delivery scope, risk, and timeline Possesses strong rapid prototyping skills and can quickly translate concepts into working code Provide technical guidance and mentorship to junior developers Contribute to both front-end and back-end development using cloud technology Develop an innovative solution using generative AI technologies Conduct code reviews to ensure code quality and alignment to standard methodologies Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations Stay updated with the latest trends and advancements Work closely with the product team, business team, and other partners Design, develop, implement, and maintain applications, including configurations, custom reports, interfaces, and enhancements Analyze and understand the functional and technical requirements of applications, solutions and systems, and translate them into software architecture and design specifications Develop and implement unit tests, integration tests, and other testing strategies to ensure the quality of the software Work on integrating applications with other systems and platforms to ensure seamless data flow and functionality Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently Design and implement systems and processes to improve the reliability, scalability, and performance of applications Develop and maintain monitoring tools and dashboards to track system health, performance, and availability Respond to and resolve incidents promptly, conducting root cause analysis and implementing preventive measures Implement and maintain security measures to protect systems from unauthorized access and other threats What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of Computer Science, IT or related field experience OR Bachelor’s degree and 6 to 8 years of Computer Science, IT or related field experience OR Diploma and 10 to 12 years of Computer Science, IT or related field experience Preferred Qualifications: Functional Skills: Must-Have Skills Have strong eye for business. Can demonstrate a deep understanding of pharma industry regulations and its compliance requirements Have excellent knowledge of submission publishing systems like Lorenz’s docuBridge application and Disclose from Citeline Have knowledge of ClinicalTrials.gov and EudraCT Have good knowledge of Regulatory Veeva Vault Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation and fostering the development of talent. Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Experience in applying technology standard process methodologiesScaled Agile (SAFe), ITIL, etc. Strong knowledge of information systems and network technologies Good-to-Have Skills: Strong knowledge of eCTD specification and highly regulated (GxP) systems Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle of GxP Systems. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytical/critical-thinking and decision-making abilities. Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Professional Certifications (please mention if the certification is preferred or mandatory for the role): ITIL (preferred) Scaled Agile Framework (SAFe) for Teams (preferred) Veeva Vault platform Certified (preferred) Soft Skills: Excellent analytical and solving skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. Equal opportunity statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com

We are currently hiring for DSA I role with a minimum of 3 to 5 years Of experience in Pharmacovigilance Perform triage & intake of ICSR received daily in ARGUS databases. Ensure data entry of ICSR in ARGUS Knowledge In Aggregate Reporting is Must Required Candidate profile Require 3 to 5 years of pharmacovigilance case processing experience. Responsible for coding events using MEDDRA Any Life Sciences(B pharm/M Pharm/ Pharm D, Life Sciences, Nursing, BDS, BPT)

We are currently hiring for DSA I role with a minimum of 1 year experience in Pharmacovigilance Perform triage & intake of ICSR received daily in ARGUS databases. Ensure data entry of ICSR in ARGUS Required Candidate profile A minimum of 1 year pharmacovigilance case processing experience. Responsible for coding events using MEDDRA Any Life Sciences(B pharm/M Pharm/ Pharm D, Life Sciences, Nursing, BDS, BPT) are Eligible

Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 95 b) For Position in Bangalore Search : Job Code # 98

Hi , We are hiring for Leading ITES Company for Data Management Study Point of Contact (DMSPOC) Profile. Job Description: To provide end to end data management services and project management of studies. Ensure compliance with SOPs and training. Primary point of escalation for issue management. Accountable for DM deliverables (including quality and timing) on the project and will be required to provide regular status updates on data completeness, cleanliness to the Data Manager. Point of contact for client POC. Attend meetings with Study Lead Data Manager (SLDM) as and when required, provide inputs to the required documents and activities throughout the course of the trial. Ensure that the timelines & quality are met as per study requirement. Resource estimation for the study and ensuring right resources are available for the study based on requirement. To oversight the end-to-end data management activities for assigned studies. Risk identification, mitigation and issue escalation to the appropriate stakeholders. Skillsets required: Ability to represent Data Management at all levels and is capable of targeting information to the respective audience. Ability to influence key project roles or Study Team members to meet the overall goal of the study. Ability to build influential networks with client and stakeholder management. Ability to develop solutions for cross functional challenges. Develops recommendations beyond own area of expertise. Knowledge of ICH GCP & CDISC requirements. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 297 b) For Position in Pune Search : Job Code # 298 c) For Position in Bangalore Search : Job Code # 299

Hi , WE are hiring for Leading ITES Company for SAS Programmer & CDB Programmer ( J Reviewer/Python/SAS) Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Nagpur Search : SAS + CDB Programmer Nagpur (Job Code # 85) b) For Position in Bangalore Search : SAS + CDB Programmer Bangalore (Job Code # 86)

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 54 b) For Position in Pune Search : Job Code # 55

We are Hiring for Leading ITES Company for Medical Reviewer Profile Pls Apply, We shall call back the relevant profiles. Experience :- Min 1 years of experience in Medical Reviewer domain Job Description for Medical Reviewer Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. • Ensure compliance with global and local procedural documents and local implementation of client. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 47 b) For Position in Pune Search : Job Code # 48 c) For Position in Nagpur Search : Job Code # 49

Overview THE COMPANY Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK. Our unique approach to data analysis, The Phastar Discipline, has led us to build a reputation for outstanding quality. With this as our core focus, were looking for talented individuals who share our passion for quality and technical expertise to join our team. WHY PHASTAR Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment. Whats more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, youll also be helping to save the planet! THE ROLE We are seeking a Senior Programmer to work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines working independently in this area; producing, reviewing and updating complex dataset specifications (including efficacy); creating and debugging complex macros; reviewing Statistical Analysis Plans (SAPs), including study specific ISS/ISE and DSMB SAPs and output shells with a view to commenting from a programming perspective. Excellent team work ethos, proactive at managing workload, willingness to help others and learn new skills from working in a team environment. This position is remote (although can be office based or hybrid, depending on your location) and will involve occasional travel to events throughout the year. Responsibilities Program and validate datasets and SDTMs, including complex efficacy, labs, etc. Become independent technical expert Program complex non efficacy outputs/ figures Perform Senior Review and Deliver QC of non- statistical output Become involved in developing the standard macro library and take responsibility to implement standard macros within a study Validate and perform User Acceptance Testing (UAT) on standard macros Identify macros requirements, communicate and perform training Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc. Implement and coordinate development and maintenance of PHASTAR standard specifications Be an SDTM and ADAM expert providing consultancy, advice and training Be an CRT expert providing consultancy, advice and training Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements Implement and coordinate the development and maintenance of PHASTAR CRT tools Become familiar with and follow study documentation Initiating projects and ideas for furthering programming development Ensure the principles in the PHASTAR checklist are followed rigorously Develop archiving systems and processes Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery Liaise with Study Statistician and Project Manager regarding resourcing and deliverables Responsible for study level resources Attend and input to company resourcing meeting Point of contact for programming issues for the team, proactively ensuring everything is working cohesively Persuade stakeholders to follow best practice within a trial Develop and deliver company-wide training as and when required Identify areas where new processes are required Create, review and update processes and SOPs Qualifications Ability to lead Able to work on complex programming ISS/ISE experience preferred Have written complex macros. Educated to BSc or above within Computer Science, Mathematics or a Science related discipline APPLY NOW With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment. Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in the UK as this role can be carried out remotely. Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all. Important notice to Employment businesses/Agencies Phastar 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 Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. 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 Phastar. Phastar 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.

Overview We have an exciting role of Medical Writer to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. Responsibilities Lead and manage a team, providing guidance, mentorship, and support to ensure their professional growth and enhance the quality of output Develop a refined understanding of the brand, disease, and the overall therapeutic/treatment category. Ensure all content is created with appropriate tone, style, and structure based on brand strategy, creative brief, and client expectations Demonstrate a sound understanding of healthcare/pharmaceutical advertising communication requirements Ability to understand appropriate medical/technical documents (clinical studies, product monographs, publications) and translate them into compelling messages and content for a wide variety of audiences Demonstrate superior writing skills and a high level of professional craftsmanship (referencing, annotating) Familiar with modular content and omnichannel marketing - the ability to develop and maintain content matrix and core claims documentation Play the role of a leader when managing a team, exhibit leadership skills and motivate them when required Demonstrate ability to set priorities while handling multiple tasks Keep track resource allocation, and project progress, providing regular updates and reports to management Collaborate with clients and account managers to address feedback, incorporate changes, and ensure client satisfaction Manage multiple projects simultaneously, allocating resources effectively and maintaining effective communication with cross-functional teams and clients Conduct performance evaluations, identify training needs, and provide professional development opportunities for the design team Qualifications 11+ years of experience in healthcare communications agencies (AMA experience is preferred) Bachelor's degree or equivalent experience with a focus on pharma/science/medicine Portfolio containing work samples that demonstrate medical writing for a variety of communication forms (e.g., sales aids, direct mail, websites, social media) for a variety of audiences (e.g., healthcare professionals, patients, consumers) AMA Style Guide knowledge (certification not mandatory) Experience with referencing and annotating, and client MLR submissions requirements An ability to understand and process healthcare information Able to multi-task in a faced paced environment as a member of a highly collaborative team The desire to work with a diverse group of teams, projects, and clients Strong conceptual ability, standout creative thinking, and top-notch writing skills

We are looking for an Associate Content Editor to join our Clinical Studies team in Hyderabad . This is an amazing opportunity to work on Cortellis Clinical Trial Intelligence and Cortellis Drug Discovery Intelligence. The team consists of 20 people. We have a great skill set in Clinical and we would love to speak with you if you have skills in Clinical/Drugs As an Associate Content Editor in Clinical team, you will be responsible for actively seeking out information about Clinical Studies, analyze, cross reference, and update all new or previously updated information in the clinical records from various sources, which includes scientific meetings, conferences, trial registries, press releases and other possible internet sources. About You Education (BPharma/M Pharma/MSc in Biotechnology, Microbiology) Work experience (0-1 year of experience in analyzing and updating clinical reports) Knowledge, skills, or abilities (In-depth knowledge of clinical trials, pharmaceutical drug pipelines, drug development and clinical phases) Excellent English written and verbal communication skills. It would be great if you also had . . . Experience in secondary research related to clinical information What will you be doing in this role? Maintain Clarivate database with up-to-date and accurate Clinical trials information from a range of information sources Accountable for the delivery of weekly targets Ensure quality standards are observed Ability to understand and interpret complex and detailed Trials & Drugs related information from source material An inquisitive, analytical mind with strong problem-identification and solving skills Hours of Work Working days Monday to Friday, working hours 9AM to 6PM IST, Hybrid working mode.

Hi We are looking to hire Narrative Medical Writers for our Client. Please go through the JD and Apply Role : Graduate or post graduate in Pharmacy, Nursing or life sciences. Certification in Medical writing or Diploma in clinical research would be desirable. Preferred experience for the Author role: Preferably 1 to 2 years of experience in medical writing domain. Life science graduate with 1 to 3 years of experience Responsibilities of Author: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category 4. Attention to detail, work under stringent timelines on a need basis, and switch between different projects, as required 5. Be responsible for the quality and timelines of the deliverables as designated/allocated in the project. 6. Proactive communication with lead narrative writers to meet the narrative writing quality and timelines 7. Complete assigned training within stipulated timelines 8. Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the client requirements To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 365 b) For Position in Bangalore Search : Job Code # 366 c) For Position in Hyderabad Search : Job Code # 367

Hi, We are hiring for leading ITES Company for Narrative Medical Writing Profile . Job Description Graduate or post graduate in Pharmacy, Nursing or life sciences. Certification in Medical writing or Diploma in clinical research would be desirable. Preferred experience for the Author role: Preferably 1 to 2 years of experience in medical writing domain. Life science graduate with 1 to 3 years of experience Responsibilities of Author: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category 4. Attention to detail, work under stringent timelines on a need basis, and switch between different projects, as required 5. Be responsible for the quality and timelines of the deliverables as designated/allocated in the project. 6. Proactive communication with lead narrative writers to meet the narrative writing quality and timelines 7. Complete assigned training within stipulated timelines 8. Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the client requirements Key Skills: a) Grad or PG in Nursing, Pharmacy or Life Sciences b) 1 to 2 years of experience in medical writing To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Noida Search : Copy and Paste the link below https://outpace.in/job/narrative-medical-writing-4/

Hi We are looking forward to hire Medical Monitor for our Client. Please go through the JD and Apply Responsibilities: Review protocol and provide suggestions Respond to queries/ clarifications from EC/ IRBs Answer medical questions from sites or project team Respond to queries from sites with regard to protocol Attend drug safety meetings/ external meetings Patient eligibility review Review AE/ SAEs Protocol training to site staff, CRAs etc Attend, participate/ present in investigator meetings Qualification: MBBS/ MD qualification Eligibility: 3 year+ of clinical trial experience Familiar with clinical trials operations Good English communication skills Proficiency in using Microsoft office To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 362 b) For Position in Pune Search : Job Code # 363 c) For Position in Bangalore Search : Job Code # 364

Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Pune Search : Job Code # 96 b) For Position in Nagpur Search : Job Code # 97

Basic Section No. Of Openings 2 Grade 1A Designation Trainee Coder Closing Date 16 May 2025 Organisational Country IN State TAMIL NADU City COIMBATORE Location Coimbatore-II Skills Skill Healthcare Medical Coding Biotechnology Microbiology CPT Medical Billing Molecular Biology GMP HIPAA Biochemistry Education Qualification No data available CERTIFICATION No data available About The Role Role Description Overview: Trainee Coder is accountable to manage day to day activities of coding the patients chart & diagnosis report. Responsibility Areas: To review emails for any updates Updating/Clearing the production/pending reports Other miscellaneous work that requires coding expertise Coding or auditing charts, based on requirements Prepare and Maintain status reports. Understand the client requirements and specifications of the project Meet the productivity targets of clients within the stipulated time. Ensure that the deliverables to the client adhere to the quality standards.

Hi, We are hiring for the ITES Company for the Clinical SAS + SQL Programmer Profile. Job Description: Minimum 4 years of experience in any CDMS application. To perform a wide range of Clinical Data Management activities resulting in high quality database within stipulated timelines. To provide expertise in programming concepts to the Data Management team Must be able to develop the connection with the stake holders by pro-actively communicating over the calls and handling the queries by resolving them on the spot or later depending on the nature of the problem. Must be able to contribute the solutions to the DMs or Medical scientist for their New requirements either programmatically or convincing them with the technical limitations, if any, along with providing alternative solution. Must have capability to develop new Macros in SAS or modify any SAS Macros that are used globally throughout studies as a part of automation. Preferred Skills: Excellent interpersonal and communication skills Capability to lead by motivation and exle. Strong knowledge in SAS macros is required. General knowledge of Clinical Trials and Pharmaceutical Industry Oracle/PL SQL, CDMS like SAS, Inform etc Key Skills: a) Minimum 4 years of experience in any Clinical Data Management application. b) Should have Oracle/PL SQL, CDMS like SAS, Inform etc c) Any Medical Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Pune Search: Job Code # 483 b) For Position in Bangalore Search: Job Code # 484 c) For Position in Hyderabad Search: Job Code # 485

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines b) Qualifications - Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 54 b) For Position in Pune Search : Job Code # 55