Clinical Trial Specialist with Regulatory Expertise
3 weeks ago
Company Overview
Lifelancer is a leading talent-hiring platform in Life Sciences, Pharma, and IT. We connect talented professionals with opportunities across pharma, biotech, health sciences, healthtech, and IT domains.
Salary
The estimated annual salary for this role is $65,000 - $85,000, depending on qualifications and experience.
Job Description
We are seeking a skilled Clinical Trial Specialist to join our team. As a Clinical Trial Specialist, you will be responsible for developing awareness of regulatory legislation, guidance, and practice in assigned regions/countries. You will work closely with senior staff to complete activities for clinical trial applications performed according to European Clinical Trials Regulation No 536/2014 in the Clinical Trials Information System (CTIS).
- Complete Part I application information in Clinical Trial Information System (CTIS)
- Accurately upload all Part I and Part II documents to CTIS
- Initiate the payment process for Part I and/or Part II submission fees and seek approval from Global Regulatory Submissions Lead (GRSL) colleagues
- Monitor CTIS and promptly inform GRSL of all received alerts in CTIS
- Ensure timely tracking of all submissions and approvals (decisions) in applicable tracking tools
- Upload the final submitted package to the Trial Master File and perform functional reviews as applicable
- Perform a review of final submission documents as applicable and specifically perform QC of Part II applications (as delegated)
- Submit application/notifications in CTIS upon permission of GRSL
- Ensure high-quality documents are uploaded and filed and systems are updated on an ongoing and timely basis making Fortrea ready for an audit at any time
- Escalate study issues appropriately and in a timely fashion
- Attend team and company meetings as applicable
- Perform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable)
Required Skills and Qualifications
To be successful in this role, you should have:
- Strong knowledge of regulatory legislation, guidance, and practice in assigned regions/countries
- Excellent communication and organizational skills
- Ability to work independently and collaboratively as part of a team
- Strong attention to detail and ability to ensure high-quality work
- Proficiency in using Clinical Trials Information System (CTIS)
Benefits
Lifelancer offers a competitive compensation package, including:
- An estimated annual salary of $65,000 - $85,000
- Opportunities for professional growth and development
- A collaborative and dynamic work environment
- A comprehensive benefits package
-
Regulatory Specialist II
4 days ago
Mumbai, Maharashtra, India Lifelancer Full timeJob Overview:Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We are seeking a highly motivated Regulatory Specialist II to join our team.About the Role:The successful candidate will be responsible for developing awareness of regulatory legislation, guidance, and practice in assigned regions/countries. This includes completing clinical...
-
Mumbai, Maharashtra, India Lifelancer Full timeCompany OverviewLifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.About the RoleWe are seeking an experienced Clinical Trial Regulatory Specialist II to join our global operations team. As part of this role, you will be responsible for developing awareness of...
-
Senior Quality Assurance Specialist
6 days ago
Mumbai, Maharashtra, India Lifelancer Full timeAbout the RoleWe are seeking a Senior Quality Assurance Specialist to join our Clinical Trials team. This is a challenging and rewarding opportunity for a highly motivated individual with a strong background in quality assurance, clinical trials, and regulatory compliance.
-
Clinical Research Associate
3 days ago
Navi Mumbai, Maharashtra, India Trigent Software Inc Full timeAt Trigent Software Inc, we are seeking a highly skilled Clinical Research Associate to join our team. This individual will play a crucial role in monitoring and managing clinical trials to ensure compliance with regulatory guidelines and Good Clinical Practice (GCP).About the Role:This position is responsible for identifying and evaluating potential study...
-
Clinical Trial Psych SDIC Specialist
3 weeks ago
Mumbai, Maharashtra, India Lifelancer Full timeJob Title: Clinical Trial Psych SDIC SpecialistLocation: Mumbai, Maharashtra, IndiaJob Type: Part-timeJob Level: ConsultantWe are seeking a Clinical Trial Psych SDIC Specialist to join our team. As a specialist in clinical trials, you will be responsible for reviewing scales administered by raters and ensuring that assessments are conducted in a standardized...
-
EDC Programmer
3 weeks ago
Mumbai, Maharashtra, India Tata Consultancy Services Full timeTata Consultancy Services is seeking an EDC Programmer to join our team in Mumbai, Pune, Bangalore, Indore, or Ahmedabad. As an EDC Programmer, you will work on Electronic Data Capture (EDC) activities and oversee the delivery of systems and documentation to support clinical studies.Key Responsibilities:Create eCRF specifications, design, develop, and unit...
-
Clinical Coding Specialist
4 weeks ago
Mumbai, Maharashtra, India Lifelancer Full timeCareer Opportunity at MedpaceMedpace is a leading global clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries.About the RoleWe are seeking a full-time Clinical Coding Specialist in Navi Mumbai, India to join our Global Clinical Coding & Support...
-
Mumbai, Maharashtra, India Lifelancer Full timeJob DescriptionA Senior Clinical Research Associate is required to work on CNS trials, evaluating case data and preparing discussions with raters. The ideal candidate will have a Master's degree in Psychology, Counseling, Psychiatric Nursing or Social Work, and at least 3 years of experience administering psychiatric assessments, ratings scales and/or...
-
Clinical Research Associate
2 weeks ago
Navi Mumbai, Maharashtra, India Trigent Software Inc Full timeJob SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Trigent Software Inc. As a key member of our clinical operations department, you will be responsible for ensuring the integrity and compliance of clinical trials.About the RoleThe successful candidate will have a strong understanding of Good Clinical Practice (GCP) and...
-
Clinical Research Associate Director
3 days ago
Navi Mumbai, Maharashtra, India USV PRIVATE LIMITED Full timeJob OverviewUSV PRIVATE LIMITED is seeking a highly skilled Clinical Research Associate Director to join our team.Key Responsibilities:Review and validate clinical trial protocols, literature searches, and study documents such as CRFs, ICFs, and eCTDs.Assess the feasibility of study proposals and quotes from various CROs.Monitor clinical trials and...
-
Clinical Data Specialist
4 weeks ago
Mumbai, Maharashtra, India Lifelancer Full timeAccelerate your career in medical research with Medpace, a leading full-service clinical contract research organization (CRO). We offer a competitive salary and benefits package.Job Title: Clinical Data SpecialistWe are seeking an eClinical Coordinator to join our Data Management/eClinical team in Mumbai, India. As a key member of the team, you will ensure...
-
Advanced Clinical Trial Data Analyst
1 month ago
Mumbai, Maharashtra, India Lifelancer Full timeAbout the RoleWe are seeking an experienced Senior Statistical Programmer to join our team at Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma and IT.As a Senior Statistical Programmer, you will be responsible for performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing...
-
Mumbai, Maharashtra, India Astellas Pharma Full timeAbout the RoleWe are seeking an experienced Regulatory Affairs Manager to join our team at Astellas Pharma India, based in Mumbai. This is a fantastic opportunity for someone who has a strong background in regulatory affairs and a passion for ensuring compliance with Indian pharmaceutical regulations.Key ResponsibilitiesMarket Authorization Planning:...
-
Director of Clinical Excellence
4 weeks ago
Navi Mumbai, Maharashtra, India HealthyLife Innovation Full timeAbout Us:HealthyLife Innovation is a trailblazing healthcare startup at the forefront of innovation, aiming to make life-changing solutions accessible to everyone.We are driven by a mission to discover cures for currently incurable diseases and have made significant progress, achieving an ARR of 100cr. Our clinical studies and trials demonstrate the...
-
Mumbai, Maharashtra, India Schbang Full timeAbout SchbangSchbang is a leading organization that values innovation, collaboration, and compliance.Job DescriptionWe are seeking a highly skilled Compliance Specialist to join our team. This role will play a crucial part in ensuring our company remains compliant with all relevant laws and regulations.Key Responsibilities:Develop and Implement Compliance...
-
Validation and Compliance Specialist
2 days ago
Mumbai, Maharashtra, India Maxis Clinical Sciences Full timeJob OverviewAt Maxis Clinical Sciences, we are seeking a highly skilled Validation and Compliance Specialist to join our team. This role is critical in ensuring the adherence of our computerized systems to regulatory requirements and maintaining the highest level of quality assurance.Key Responsibilities:Develop and implement validation strategies for...
-
Clinical Validation Specialist
2 weeks ago
Mumbai, Maharashtra, India Lifelancer Full timeMedpace is a full-service clinical contract research organization (CRO) that provides Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.We are seeking a Clinical Validation Specialist to join our team in Mumbai, India. The estimated salary for this position is $75,000 - $90,000 per annum, based on...
-
Senior Validation Specialist
3 days ago
Mumbai, Maharashtra, India Maxis Clinical Sciences Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Validation Specialist to join our team at Maxis Clinical Sciences. In this key role, you will be responsible for leading validation activities across various systems, processes, and equipment in our FDA-regulated environment.Key ResponsibilitiesDevelop and execute validation protocols,...
-
Clinical Data Specialist
6 days ago
Mumbai, Maharashtra, India Lifelancer Full time**Estimated Salary: 6.5 lakhs - 8.5 lakhs per annum**About Medpace and LifelancerMedpace is a global clinical contract research organization (CRO) that provides phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries.Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT that connects...
-
Validation Specialist
3 weeks ago
Mumbai, Maharashtra, India Maxis Clinical Sciences Full timeAbout Maxis Clinical SciencesWe are a leading clinical sciences company seeking an experienced Validation Specialist to join our team. As a key member of our quality assurance department, you will play a vital role in ensuring the compliance of our computerized systems with GxP regulations.Job SummaryThe successful candidate will be responsible for...