Senior Clinical Trial Operations Manager

2 days ago

Davangere, Karnataka, India beBeeClinicalResearch Full time ₹ 35,00,000 - ₹ 50,00,000
Senior Clinical Research Manager Job Description

This is a senior-level position that oversees the management of clinical research projects, ensuring they are completed on time and within budget. The manager will be responsible for supervising research teams, collaborating with cross-functional departments, and providing strategic direction for clinical research activities.

Key Responsibilities:

  • Plan, initiate, and manage clinical research projects from start to finish.
  • Coordinate and oversee the execution of clinical trials, ensuring adherence to protocols, timelines, and budgets.
  • Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards.
  • Provide oversight on the recruitment, enrolment, and monitoring of clinical trial subjects.
  • Manage relationships with clinical research organizations (CROs), investigators, and external vendors.

Team Leadership:

  • Lead and mentor clinical research staff, ensuring they are trained and performing effectively.
  • Assign tasks and responsibilities to team members based on project needs.
  • Develop training programs and provide ongoing professional development for research teams.

Regulatory Compliance:

  • Oversight the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications.
  • Monitor compliance with federal, state, and local regulations, as well as company policies.
  • Ensure timely reporting of adverse events and ensure the study meets ethical and regulatory standards.

Study Design & Protocol Development:

  • Work with scientific and medical teams to develop clinical trial protocols.
  • Ensure protocols meet study objectives, regulatory standards, and ethical guidelines.
  • Evaluate feasibility and risk of proposed studies.

Data Management and Reporting:

  • Ensure data collection, monitoring, and analysis are conducted efficiently and accurately.
  • Review and analyze clinical trial data to ensure quality and integrity.
  • Prepare and present progress reports to senior leadership and stakeholders.

Budget and Resource Management:

  • Develop and manage project budgets, ensuring that clinical trials are completed within financial constraints.
  • Oversee resource allocation, including personnel, equipment, and materials.

Collaboration and Communication:

  • Foster communication between internal teams, external partners, and key stakeholders.
  • Collaborate with clinical research coordinators, data managers, and other departments to ensure effective study execution.
  • Resolve any issues related to clinical trial execution and provide solutions.

Continuous Improvement:

  • Identify areas for process improvement in clinical trial execution and management.
  • Implement best practices to optimize research efficiency and compliance.

Qualifications:

  • Education: Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred).
  • Experience: 8 to 18 years of Experience in clinical research, with at least 2-3 years in a managerial or supervisory role.
  • Skills: Strong project management, leadership, and organizational skills.
  • Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.
  • Proficiency in clinical research software and data management systems.
  • Strong problem-solving and decision-making abilities.

Certifications:

  • Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred (or equivalent).

  • Clinical Trial Specialist

    7 days ago

    Davangere, Karnataka, India beBeeClinicalResearchAssociate Full time ₹ 8,00,000 - ₹ 15,00,000

    Clinical Research Associate">Job Summary: We are seeking a highly motivated Clinical Research Associate to play a key role in the clinical trials process.Clinical Research Associates work closely with investigators and research teams to ensure compliance with regulations and guidelines. Their primary responsibilities include coordinating on-site trial...

  • Senior Dermatologist Clinical Trials Lead

    3 days ago

    Davangere, Karnataka, India beBeeDermatologist Full time ₹ 15,00,000 - ₹ 25,00,000

    We are seeking a skilled Dermatologist to lead clinical trials in the field of dermatology. This is an exciting opportunity for a medical professional to make a meaningful contribution.Key Responsibilities:Conduct clinical trials as Investigator or Co-investigatorPerform dermatological evaluations for diagnosing and treating various skin care and hair care...

  • Senior Clinical Operations Manager

    1 week ago

    Davangere, Karnataka, India beBeeClinical Full time ₹ 15,00,000 - ₹ 22,00,000

    Job Title: Associate Clinical LeadProject Overview:As a Senior Clinical Operations Manager, you will play a crucial role in overseeing the global unblinded CRA team and providing technical support for unblinded clinical operations. This position offers an exciting opportunity to utilize your expertise in clinical research to drive project success.Key...

  • Data Management Specialist

    2 days ago

    Davangere, Karnataka, India beBeeClinical Full time ₹ 2,00,00,000 - ₹ 2,25,00,000

    Senior Clinical Data ManagerWe are seeking a seasoned Senior Clinical Data Manager to lead our team. This individual will be responsible for managing clinical trial data, ensuring accuracy and efficiency in data operations.Lead the management of clinical trial data with a strong focus on quality and compliance.Develop and implement effective data management...

  • Central Clinical Data Specialist

    3 days ago

    Davangere, Karnataka, India beBeeClinical Full time ₹ 80,00,000 - ₹ 1,50,00,000

    Job OpportunityWe are seeking a highly skilled Clinical Monitoring Expert to play a pivotal role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.The ideal candidate will possess a strong understanding of ICH GCP guidelines and the clinical...

  • Clinical Quality Assurance Professional

    6 days ago

    Davangere, Karnataka, India beBeeQuality Full time ₹ 15,00,000 - ₹ 20,25,000

    Clinical Quality Assurance SupportWe are seeking a highly experienced Clinical Quality Assurance Specialist to provide day-to-day support across ongoing clinical trials. This individual will play a key role in guiding study teams, maintaining compliance with Good Clinical Practice (GCP), and ensuring quality oversight.Key ResponsibilitiesProvide QA expertise...

  • Clinical Research Documentation Specialist

    1 week ago

    Davangere, Karnataka, India beBeeClinicalResearch Full time ₹ 15,00,000 - ₹ 20,00,000

    Job Title: Clinical Research Documentation SpecialistAbout the Role:We are seeking an experienced Clinical Research Documentation Specialist to join our team. As a key member of our clinical operations group, you will play a critical role in developing high-quality clinical trial documents.Key Responsibilities:Developing Key Clinical Trial...

  • Chief Compliance Officer

    1 day ago

    Davangere, Karnataka, India beBeeClinicalCompliance Full time ₹ 19,99,950 - ₹ 24,99,900

    Job Title: Clinical Quality Assurance Compliance & TrainingExperience: 5 plus years.Location: Mumbai.Type: Full-time.Experience Level: Senior Manager/Senior Manager.Department: Clinical Research Department This role will be responsible for oversight on end-to-end clinical trial activities from a quality perspective. The candidate will be accountable for...

  • Long-Term Contract Clinical Systems Tester

    7 days ago

    Davangere, Karnataka, India beBeeClinical Full time ₹ 90,00,000 - ₹ 1,20,00,000

    Job OpportunityWe are seeking a Clinical Systems Tester to support the validation and testing of clinical trials in a decentralized environment. This role requires adaptability across various digital systems and patient-facing technologies.Author test scripts aligned with protocol requirements, utilizing Veeva EDC.Validate workflows across eCOA and IRT...

  • Strategic Clinical Data Analyst

    6 days ago

    Davangere, Karnataka, India beBeeStatistical Full time ₹ 12,00,000 - ₹ 22,00,000

    Job OpportunityThis is a Senior Statistical Programmer role where you will be working closely with a pharmaceutical client to drive the next generation of patient treatment.As a senior member of our team, you will use advanced SAS programming skills and CDISC standards expertise to support Phase I-IV clinical trials. Your focus will be on innovation and...