clinical-research

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.

We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

ICON plc

• To effectively review visit reports as per Protocol and ICON and Sponsor SOPs and to ensure the quality of reports are of the highest standards , errors are minimized and that issues are escalated as appropriate
• To follow up on action items and protocol deviations and to be a liaison between CRA, CTM and PM for timely resolution of issues.
• To act as an extension of the CTM/CTM team for the specific purpose of visit report review and approval.
• To observe and escalate safety trends in patients as identified in visit report
• Regular oversight of OMR , ICO trial (and where required Sponsor CTMS and vendor systems) to ensure key metrics, e.g. MVR and FUL timelines, Action Items and other quality metrics are being met and followed-up as necessary
• Ensure open action items and protocol deviations are escalated and followed up for timely resolution as per contract or corporate standards .
• Where required , attend project meetings and actively provide suggestions for improvement of quality of reports, provide feedback for timely and appropriate resolution of action items and report trends • Liaise with CTM to communicate any trends , outstanding issues, safety concerns or any other activity or lack thereof which may jeopardise the clinical trial delivery or patient safety.

Centralized Clinical Trial Manager

Centralized Clinical Trial Manager at ICON responsible for reviewing clinical trial site visit reports and ensuring quality standards. Act as a liaison for timely resolution of issues.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  
 
We bring together a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. 

Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. 
 
Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.

Syneos Health

• Perform medical and scientific data review on haematology clinical trials (indication anticipated myeloma or lymphoma)
• Standard data listing review (data listings, AEs, con meds, etc.)
• May complete patient profile review, standard listing data review, efficacy review and safety narrative review, PD analysis and PD review
• Will support Lead Scientist with scientific data review of clinical trial
• May support with additional CS tasks beyond scope of data review at the discretion of the Lead CS team however the primary role will be scientific data review
• Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan)
• Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans
• Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews
• Authors medical data queries and reviews query responses, approves query closure in association with Medical Director
• May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed
• Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed
• Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met
• Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review
• Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety
• Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of-scope tasks to the project leads in a timely manner
• Attends at Trusted Process meetings and may participate in internal and external audits
• Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology
• Adheres to all data privacy guidelines, ICH, and GCPs, all enterprise policies, standard operating procedures, work instructions, and project plans
• Adheres to customer policies and standard operating procedures, as required in project plans

Clinical Scientist

Clinical Scientist performing medical and scientific data review for haematology clinical trials at Syneos Health. Supporting lead scientists and managing project scopes to ensure deliverables.

Biorasi is a global, award-winning full-service contract research organization (CRO) that specializes in accelerating clinical trials for small and midsize pharmaceutical and medical device companies. The company focuses on rapid trial completion, offering decentralized and virtual solutions, as well as patient engagement and recruitment strategies. With expertise in therapeutic areas such as neurology, dermatology, oncology, and rare diseases, Biorasi prides itself on delivering high-quality outcomes with significant speed and agility. The organization uses cutting-edge technology and innovative approaches to enhance patient recruitment, site activation, and data management, making clinical trials faster and more efficient.

For over 20 years, Biorasi has been to go-to CRO (Contract Research Organization) for small to midsized biopharma companies, optimizing speed-to-market solutions across global clinical trials in oncology, neurology, dermatology, and cell and gene therapy. Our #OneTeam of leaders and clinical study experts focus on the qualities necessary to succeed in today’s clinical trial industry – flexibility, reliability, and transparency. 

It is Biorasi’s mission to be a catalyst for growth, innovation, and evolution in the field of clinical research – moving the industry forward while improving results for our partners and outcomes for their patients. Our culture is based on our strong commitment to building true partnerships with our sponsors. We approach all of our trials with urgency, commitment, and resolve. 

Biorasi is able to directly support studies in the Americas, Europe, and APAC. We have received multiple accolades including placement in the INC 500 and 5000 list of fastest-growing companies in America, Frost and Sullivan’s Entrepreneurial Company of the Year for the CRO Industry, and the CRO Leadership Award from Life Science Leader magazine.

Biorasi

• Manages or support all clinical aspects of a study, including assessing operational feasibility; assist in managing Clinical study timelines and metrics; provides study-specific training and leadership to clinical team; prepares and presents project debriefings, as required; plan, execute, lead or support study-specific meetings (e.g., Study Management Meetings, investigator meetings). Responsible for ensuring that Clinical Team delivers timely and high-quality project
• Site Management: Track and manage subject recruitment at all study sites. Oversee or supports the management of study Monitoring Visits, and review and approval of Monitoring Reports. Monitor study/site performance on an ongoing basis and escalate any infringements, breaches, and misconduct, fraud and trends at sites. Ongoing protocol deviation tracking, reporting, and trending. Notify sites of updates on global study information and updates.
• Study Start-Up: Uses operational and therapeutic expertise to optimize trial execution. Determine or contribute to the list of approved sites for selection visits. Plan or assist in allocating clinical team resources. Determine, develop and implement tracking and reporting specifications. Works with the study team to design clinical protocol; provides input for the design of the ICF template, source documents worksheets, and CRFs. Prepares and/or reviews study-related documents to include, visit report templates and annotations, clinical logs, forms, manuals and guidelines.
• Document and Supplies Management: Oversee or support the collection, review and filing of site essential documents, and maintenance of the TMF. Coordination of IP and clinical study supplies and oversee or support the overall tracking of clinical supplies at site in coordination with established systems such as IWRS, EDC, CTMS, or vendor-specific
• Compliances: Follow international GCP guidelines/regulations, SOPs, and study protocol for executing clinical studies. Participates in the planning of quality assurance activities and coordinates or support the resolution of audit findings.
• Staff Management: Support Clinical Management Team or act as functional Manager to Clinical operations staff allocated on assigned projects. Provides coaching and guidance to junior Clinical staff.
• Daily interaction with the Clinical Management Team and members of the cross-functional study team.
• Support study management team in selecting sites and countries; develops relationships with investigators and site staff.
• Support the cross-functional study team as needed; frequent cross-functional interactions with internal and external personnel (e.g., regulatory affairs, investigators, vendors, etc.).
• Lead or partake in regular team meeting / teleconferences; Participate/present at Client Presentation Meetings as necessary; Participate/present at Investigator Meetings as necessary.
• Communicate any out of scope issues to the Senior Clinical Management Team or Project Management Team as soon as identified.
• Other duties as assigned.

Clinical Trial Manager

Clinical Trial Manager overseeing clinical research studies for Biorasi, LLC. Managing trial execution, compliance, and team collaboration in a hybrid work environment.

• Serves as lead biostatistician for simple to complex clinical studies.
• Develops statistical analysis plans and reporting specifications.
• Responsible for statistical aspects of CRF design and edit specifications.
• Performs statistical analyses and interprets results for simple to complex clinical studies.
• Reviews simple to complex randomization specifications and dummy randomization schemes.
• Participates in bid defense meetings.

Senior Biostatistician I / II

Senior Biostatistician I at ICON, leading design and analysis of clinical trials to advance innovative treatments and therapies.

• Recognize, exemplify and adhere to Accellacare's values
• Serve as the first point of contact for help desk incidents
• Interface with users to identify and support requests
• Lead quick win efforts and participate in organizational projects
• Interface with IT/Vendor teams to resolve issues
• Capture user feedback and provide input to management
• Review system data to identify training needs
• Coordinate development and review of training material
• Participate in system testing and engage with users for feedback

Analyst, Clinical Research Systems, Reporting

Analyst role in clinical research systems and reporting at ICON, fostering a culture of innovation. Engaging with users for support and improving system processes.

Hybrid Clinical Researchers roles in India

Browse 5 hybrid clinical researchers roles hiring in India plus related opportunities such as medical writer, biostatistician, data scientist, clinical operations, medical director and medical reviewer.

5 jobs found

Centralized Clinical Trial Manager

ICON plc

Clinical Scientist

Syneos Health

Clinical Trial Manager

Biorasi

Senior Biostatistician I / II

ICON plc

Analyst, Clinical Research Systems, Reporting

ICON plc