Current jobs related to Clinical Trial Associate - gurugram - Lifelancer
-
Clinical Trial Associate
5 months ago
Gurugram, Haryana, India Takeda Pharmaceutical Full time**OBJECTIVES**: - _Perform day-to-day management of CTMS and eTMF, including oversight of the review and approval of eTMF documents and generation of reports to measure completeness, accuracy, and timeliness of the eTMF, as per applicable regulations and guidelines, and Takeda requirements_ **ACCOUNTABILITIES**: - _Lead the development of the study...
-
Trial Capabilities
5 months ago
Gurugram, Haryana, India HCAH Full timeClinical Trial Responsibilities - Assist investigator site activation activities, including compilation and submission/notification of regulatory documents. - Assisting Trial Capabilities Associate on study document management & tracking for IRB/IEC submissions throughout the study. - Track site compliance to required training to effectively drive timelines...
-
Clinical Trial Coordinator
5 months ago
Gurugram, Haryana, India MSD Full time**Clinical Trial Coordinator**: Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as...
-
Trial Capabilities Manager
5 months ago
Gurugram, India Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. The Trial Capabilities Manager provides clinical trial capabilities in support of clinical development. The Manager is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing...
-
Research Associate
4 months ago
Gurugram, Haryana, India medONE Pharma Solutions Full timeWe are currently looking for passionate, and committed professional to join our team as Research associates. B. Pharm, M. Pharm with work experience and/or Post Graduate Diploma in clinical research, preferred. The ideal profile will have 0.5- 2 years of experience. An equivalent combination of education, training and experience may be accepted in place of a...
-
Research Associate
4 months ago
Gurugram, Haryana, India medONE Pharma Solutions Full timeWe are currently looking for passionate, and committed professional to join our team as Research associates. B. Pharm, M. Pharm preferred or Bachelor's Degree in a Life Sciences discipline or health care, with Post Graduate Diploma in clinical research. The ideal profile will have 0.5- 2 years of experience. An equivalent combination of education, training...
-
Central Report Reviewer
5 months ago
Gurugram, Haryana, India Syneos Health Clinical Full time**Description** **Central Report Reviewer** 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. Our Clinical Development model brings the customer and the patient...
-
Senior Analyst
3 weeks ago
gurugram, India Everest Group Full timeAbout Everest GroupConfident decisions driven by deep expertise and tenacious research.Everest Group is a research firm helping business leaders confidently navigate today’s market challenges, driving maximized operational and financial performance and transformative experiences. Our deep expertise and tenacious research focused on software, technology,...
-
Senior Analyst
1 month ago
gurugram, India Everest Group Full timeAbout Everest Group Confident decisions driven by deep expertise and tenacious research. Everest Group is a research firm helping business leaders confidently navigate today’s market challenges, driving maximized operational and financial performance and transformative experiences. Our deep expertise and tenacious research focused on software, technology,...
-
Senior Analyst
5 months ago
Gurugram, India Everest Group Full timeAbout Everest GroupConfident decisions driven by deep expertise and tenacious research.Everest Group is a research firm helping business leaders confidently navigate today’s market challenges, driving maximized operational and financial performance and transformative experiences. Our deep expertise and tenacious research focused on software, technology,...
-
Senior Analyst
1 month ago
gurugram, India Everest Group Full timeAbout Everest GroupConfident decisions driven by deep expertise and tenacious research.Everest Group is a research firm helping business leaders confidently navigate today’s market challenges, driving maximized operational and financial performance and transformative experiences. Our deep expertise and tenacious research focused on software, technology,...
-
Senior Analyst
5 months ago
gurugram, India Everest Group Full timeAbout Everest Group Confident decisions driven by deep expertise and tenacious research. Everest Group is a research firm helping business leaders confidently navigate today’s market challenges, driving maximized operational and financial performance and transformative experiences. Our deep expertise and tenacious research focused on software, technology,...
-
Senior Analyst
2 weeks ago
gurugram, India Everest Group Full timeAbout Everest Group Confident decisions driven by deep expertise and tenacious research. Everest Group is a research firm helping business leaders confidently navigate today’s market challenges, driving maximized operational and financial performance and transformative experiences. Our deep expertise and tenacious research focused on software, technology,...
-
Senior Analyst
4 months ago
Gurugram, India Everest Group Full timeAbout Everest GroupConfident decisions driven by deep expertise and tenacious research.Everest Group is a research firm helping business leaders confidently navigate today’s market challenges, driving maximized operational and financial performance and transformative experiences. Our deep expertise and tenacious research focused on software, technology,...
-
Manager-1-clinical Quality
4 months ago
Gurugram, Haryana, India Sun Pharmaceutical Industries Ltd Full time**Job Purpose** The Clinical Process and Quality Manager (CPQM) is primarily responsible to support all Global Development (GD) functions for ensuring audits and inspection readiness through periodic quality control activities. **Key Roles and Responsibilities** - Acts as Quality Partner for assigned Global Development Functions and drives Quality...
-
Research Associate
5 months ago
Gurugram, Haryana, India cocentrus Full timeHi, We are hiring for **Healthcare Research Associate **profile for **Gurgaon** Location please find the job responsibility as below: - **Job Title**: Healthcare Research Associate **Experience ** : 0 month to 3 years **Location**: Gurgaon Sector-18 **Working Days ** : Monday To Friday **Shift Timings ** : Rotational Shift Depends on projects - **2:00 PM...
-
Accounts Payable Coord I
5 months ago
Gurugram, Haryana, India Syneos Health Clinical Full time**Description** **Accounts Payable Coord I** 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. Every day we perform better because of how we work together, as one...
-
Business Analyst
2 months ago
Gurugram, India UnitedHealth Group Full timeOptum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion,...
-
Clinical Research Associate
4 weeks ago
Gurugram, Haryana, India Statistical Pharma Full timeKey Responsibilities - Provide clinical study start up expertise. - Assist Lead CRA in the preparation of IRB submissions including the review of the sitespecific informed consent and assent forms - Track IRB submissions - Collect, review, and process essential documents and identify issues that site needs to address. - Communicate to site the updates needed...
-
Skin Clinic Counselor
4 months ago
Gurugram, Haryana, India Skinfinity Derma Skin Hair & Laser Clinic Full time9599813100 **Eligibility Criteria** - Any bachelor's degree from an accredited university. - Prior counseling experience of 1-2 years in a Dermatology clinic or hospital is desirable. - Strong sales conversion history. - Must possess excellent communication and interpersonal skills. **Role & Responsibilities** - Counseling the patients for skin, hair or...
Clinical Trial Associate
2 months ago
Job Description
OBJECTIVES
Perform day-to-day management of CTMS and eTMF, including oversight of the review and approval of eTMF documents and generation of reports to measure completeness, accuracy, and timeliness of the eTMF, as per applicable regulations and guidelines, and Takeda requirements
Accountabilities
Lead the development of the study specific eTMF plans for assigned clinical studies.
Perform quality control of documents submitted to the eTMF using the established acceptable criteria
Ensure clinical trial documentation is consistent with eTMF specifications, ICH-GCP guidelines, regulatory requirements, and applicable SOPs
Address eTMF questions pertaining to how documents are filed, and user questions related to the eTMF system
Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed
Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis.
Monitor and identify study-specific eTMF trends and communicate to Clinical Operations and/ or other functional teams as needed
Assist with inspection/audit related activities (e.g., preparation, correction action plans)
Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory requirements
Support Clinical Operations Lead/ Clinical Operations Manager in performing CRO oversight as per agreed parameters
Collaborate with study team leads to lead the set-up of studies, study teams and sites in the CTMS ensuring programs are configured according to the specific study requirements including countries and sites; grant access for internal and 3rd party vendor users; baseline expected deviation categories, study/visit plans, visit report letter templates and baseline milestones
Manage end-user and group permission settings.
Lead meetings to escalate trends, issues, and establish standards based on current industry standards, while problem solving and seeking appropriate endorsement across study teams and functions.
Continually assess that CTMS features are functioning properly and efficiently; track all issues observations for future enhancement, bug fixes, or ongoing needs for training of CTMS features for continuous improvement of the management of the system.
Education, Behavioural Competencies And Skills
Minimum Bachelors degree in science/healthcare field required
3+ years of relevant clinical research and TMF experience at a biotechnology, pharmaceutical company or CRO required
Previous experience working in eTMF system software; experience in Veeva Vault CTMS eTMF system software preferred
Good working knowledge of GCP and local clinical trial rules and regulations
Organizational and problem-solving skills
Superior communication, strategic, interpersonal, and negotiating skills
Proven/ stable performance records over past 2-3 years
Travel Requirements
Domestic travel may be required (20-30%), including some weekend commitments.
Limited international travel (10-20%) may be required.
Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.
Please use the below Lifelancer link for job application and quicker response.
