Jubilee Hills Hyderabad Telangana Clinical trial manager Jobs – 103 Open Jobs Today

Clinical Trial Manager
Azurity Pharmaceuticals - India —Hyderabad, Telangana
- Bachelor's degree
- EMR systems
- Leadership
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6d
Director, Global Clinical Trial Services, India
Regeneron —Hyderabad, Telangana
- Budgeting
- Leadership
- Health insurance
- Paid time off
Clinical Data Manager
QED Pharmaceutical Services —Hyderabad, Telangana
- Computer Science
- Research
- Master's degree
Project Manager Clinical Research
AXIS Clinicals —Miyapur, Hyderabad, Telangana
- Full-time
- English
- Master's degree
- Project management
Manager, Clinical Development – Clinical Sciences
Azurity Pharmaceuticals - India —Hyderabad, Telangana
- Doctoral degree
- Research
- Communication skills
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Clinical Research Associate - II
AXIS Clinicals —Miyapur, Hyderabad, Telangana
- Full-time
- Up to 50% travel
- English
- Master's degree
Project Associate -Clinical Portfolio (Hyderabad)
Syneos - Clinical and Corporate - Prod —Hyderabad, Telangana
- Full-time
Clinical Trials Project Management
Jeevan —Hyderabad, Telangana
- Medicine
- Doctoral degree
- English
R&D Clinical - Quality Compliance Senior Manager
Amgen —Hyderabad, Telangana
- English
- Master's degree
- Analysis skills
Delivery Service Manager - RDT Biometrics and Clinical Evidence
Roche —Hyderabad, Telangana
- AWS
- Analysis skills
- Machine learning
4d
Manager - Strategic Planning & Operations
Amgen —Hyderabad, Telangana
- Microsoft Powerpoint
- Word processing
- Computer literacy
Manager Centralized Study Support
Amgen —Hyderabad, Telangana
- Management
- Master's degree
- Bachelor's degree
Manager Central Monitoring
Regeneron —Hyderabad, Telangana
- Microsoft Excel
- Data analysis skills
- Microsoft Office
- Health insurance
- Paid time off
Manager - Safety & PV (ICSR)
Syneos - Clinical and Corporate - Prod —Hyderabad, Telangana
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Nursing
Specialist, Clinical Data Reporting
Regeneron —Hyderabad, Telangana
- Computer Science
- Master's degree
- Bachelor's degree
- Health insurance
- Paid time off
Project Associate -Clinical Portfolio (Hyderabad)
サイネオス・ヘルス —Madhapur, Hyderabad, Telangana
Manager - Safety & PV (ICSR)
サイネオス・ヘルス —Hyderabad, Telangana
- Microsoft Powerpoint
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Associate Digital Health Technologies Manager
Parexel —Hyderabad, Telangana
- Project management
- Bachelor's degree
- Organisational skills
1d
Principal Global Trial Associate
Bristol-Myers Squibb —Hyderabad, Telangana
- Email
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Clinical Programmer
Statistics & Data Corporation (SDC) —Hyderabad, Telangana
- Full-time
- Hybrid work
- Computer Science
- No experience needed
- SQL
- Paid time off
- Flexible schedule
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Clinical Trial Manager

Azurity Pharmaceuticals - India
Hyderabad, Telangana

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Job details

6 days ago

Qualifications

Quality assurance
Bachelor's degree
EMR systems
Clinical trials
Data science
Leadership
Communication skills
FDA regulations
Data Science

Full job description

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

About the Role:

The Clinical Trial Manager is responsible for leading the planning, execution, oversight, and delivery of early phase clinical trials. The CPM serves as the operational leader for assigned studies, partnering cross-functionally with the Clinical Development Lead / Clinical Scientist, Drug Safety, Regulatory, Data Management, Quality, and external vendors to ensure clinical trials are delivered on time, within budget, and in compliance with applicable regulations and quality standards.

Key Responsibilities

Lead the operational execution of assigned domestic or global early phase clinical trial(s) including oversight of selected vendor(s)/CRO to ensure accountability, quality, and on time delivery of key project deliverables.
Develop and manage study timelines, contract/budget negotiations, and risk mitigation plans to ensure delivery on timeline and financial goals are met.
Initiate and manage request for proposal activities for assigned clinical studies or clinical development vendors, including CROs, specialty lab vendors, bioanalytical vendors, etc.
Lead study execution team comprised of cross-functional representatives from Regulatory, Drug Safety, Medical, Drug Supply, Data Management, Biostatistics, and Quality to oversee CRO vendors and ensure study excellence.
Manage clinical development vendors according to vendor oversight plans.
Oversee all study-level data monitoring activities, reviews monitoring visit reports, and conducts Sponsor oversight monitoring visits as required.
Responsible for monthly Protocol Deviation (PD) review, including oversight of CRA documentation and collaboration with Medical Monitor for medical review.
Prepares and/or reviews study-related study plans/documents; reviews site study documents.
May assist in strategic trial design and protocol writing and reviewing / contributing to clinical regulatory documents to support upcoming programs (regulatory submissions, clinical overviews, pediatric study plans, etc.).
Strategic country/site selection with program input and ensuring consistency across all clinical projects for therapeutic area.
Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files, Trial Master File (TMF), and clinical trial registry submissions.
Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements.

Required Skills and Experience

Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related field.
10 years minimum experience in the pharmaceutical or biotechnology industry including Contract Research Organization (CRO), pharmaceutical/biotechnology company, or clinical research environment (e.g., CRA, site coordinator, drug safety specialist, regulatory-clinical specialist), including 5+ years of clinical project/trial management (PM) or equivalent clinical operations experience.
Knowledge of international regulatory requirements (FDA, EMA, GCP, GMP, GDPR).
Experience in and knowledge of the pharmaceutical development process

Preferred Qualifications

5+ years' experience of clinical trial management for early phase studies conducted in the US and India
Broad understanding of regulatory GMP requirements for IMP product packaging and supply
Excellent organizational and leadership skills.
Effective communicator who can manage multiple priorities while building strong internal relationships across multiple departments.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.

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Refine Your Search

clinical trial manager jobs in jubilee hills hyderabad telangana

Clinical Trial Manager

Director, Global Clinical Trial Services, India

Clinical Data Manager

Project Manager Clinical Research

Manager, Clinical Development – Clinical Sciences

Clinical Research Associate - II

Project Associate -Clinical Portfolio (Hyderabad)

Clinical Trials Project Management

R&D Clinical - Quality Compliance Senior Manager

Delivery Service Manager - RDT Biometrics and Clinical Evidence

Manager - Strategic Planning & Operations

Manager Centralized Study Support

Manager Central Monitoring

Manager - Safety & PV (ICSR)

Specialist, Clinical Data Reporting

Project Associate -Clinical Portfolio (Hyderabad)

Manager - Safety & PV (ICSR)

Associate Digital Health Technologies Manager

Principal Global Trial Associate

Clinical Programmer

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