APM/PM - Late Phase - Brillex Clinical Research

6 days ago

Ahmedabad Gandhinagar, India Brillex Clinical Research Pvt. Ltd. Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Role & responsibilities

  • Develop and manage comprehensive project plans, including timelines, budgets, resource allocation, and risk mitigation strategies.
  • Oversee all aspects of trial startup, including site selection, contract negotiation, IEC/IRB submissions, and study team training.
  • Monitor trial progress against established milestones and timelines, proactively identifying and addressing potential delays or roadblocks.
  • Manage project budgets, track expenses, and ensure cost-effectiveness.
  • Collaborate with cross-functional teams (e.g., medical, biostatistics, data management, regulatory) to ensure seamless project execution.
  • Manage vendor relationships, including selection, contract negotiation, and performance monitoring.
  • Serve as the primary point of contact for study sites, sponsors, and other stakeholders.
  • Facilitate effective communication among study team members, ensuring timely dissemination of information and updates.
  • Prepare and present regular project status reports to management and stakeholders.
  • Foster a collaborative and productive working environment within the study team.
  • Ensure adherence to all applicable regulations, guidelines (e.g., GCP, FDA), and company SOPs.
  • Monitor data quality and integrity, identifying and resolving any discrepancies or issues.
  • Implement quality control measures and participate in audits and inspections.
  • Maintain accurate and up-to-date study documentation.
  • Identify and assess potential risks to trial success, including patient safety, data integrity, timelines, and budget.
  • Develop and implement risk mitigation strategies to minimize the impact of potential risks.
  • Proactively monitor and manage risks throughout the trial lifecycle.
  • Provide leadership and guidance to study team members, fostering a positive and productive work environment.
  • Delegate tasks effectively, ensuring appropriate distribution of responsibilities.
  • Mentor and develop junior team members, promoting professional growth and development.
  • Perform other duties as assigned by HOD.

Preferred candidate profile

  • Bachelor's degree in a scientific or related field; Master degree preferred.
  • Thorough understanding of GCP, FDA regulations, and other relevant guidelines.
  • Proven ability to manage complex clinical trials, including budget management and vendor oversight.
  • Strong leadership, communication, and interpersonal skills.
  • Excellent organizational and time-management skills.
  • Proficiency in clinical trial management software and Microsoft Office Suite.
  • Ability to work independently and as part of a team.

  • Protocol / Medical Writer - Late Phase - Brillex Clinical Research

    1 week ago

    Ahmedabad, Gandhinagar, India Brillex Clinical Research Pvt. Ltd. Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Role & responsibilitiesResponsible for clinical trial medical science related activities like preparation of protocol, Informed consent form, CRF, other study related documents and SOPs in line with ICH GCP, Indian and global regulatory.Conduct relevant literature search for required for protocol and manuscript writing.Ensures that medical writing...

  • Medical Monitor

    1 week ago

    Ahmedabad, Gandhinagar, India Brillex Clinical Research Pvt. Ltd. Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Job SummaryThe Medical Monitor will serve as the primary medical expert for late-phase (Phase IIIV) clinical trials, ensuring subject safety, scientific integrity, and regulatory compliance throughout the study. This role involves providing ongoing medical oversight, safety data review, protocol compliance assessment, and guidance to investigators and the...

  • Morepen - Senior Vice President - Business Development - Late Phase Clinical Trials

    2 weeks ago

    Ahmedabad, India Morepen Laboratries Ltd. Full time

    Position Overview:. We are seeking an accomplished and visionary Senior Vice President - Business Development to lead and expand our late-phase clinical trial services portfolio. This executive role is pivotal in driving strategic partnerships, accelerating business growth, and positioning our organization as a trusted global partner for Phase IIb-IV...

  • Clinical Research Coordinator

    2 days ago

    Ahmedabad, Gujarat, India S3 Clinical Research Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Kickstart your career inClinical Researchwith us We atS3 Clinical Researchare looking for02 passionate internsinAhmedabadfor aGlobal Clinical Trialproject. What's in it for you? 6-month (180 days) structured internship Internship Certificate to boost your profile Incentive for top performers Best performers will behired as CRCat S3 Clinical ResearchThis is...

  • Clinical Research Associate

    7 days ago

    Gandhinagar, India Eccentric Clinical Research Pvt Ltd Full time

    Overseeing the management of clinical trials across the site to ensure they progress in accordance with contract terms and defined quality standards, protocols, SOPs, GCP, and relevant guidelines to meet local regulations. Communicating project scope, timelines, goals, technical details, and input from the Director/Project Manager to the sites throughout...

  • Clinical Research Associate

    3 days ago

    Ahmedabad, India CBCC Global Research Full time

    (CRA) (Job code: CBCCIND/CO/CRA) Work Experience: 4-8 Years Work Location: Ahmedabad, Mumbai, Bangalore, Hyderabad, Pune or Delhi Pre-Requisite Skills: onsite monitoring experience mandatory Job Requirements: - Key Responsibilities - Overall site management of clinical trials - Ensure effective communication to sites - Prepare for site visits - Assist...

  • Clinical Research Associate

    2 days ago

    Gandhinagar, GJ, IN Eccentric Clinical Research Pvt Ltd Full time

    Overseeing the management of clinical trials across the site to ensure they progress in accordance with contract terms and defined quality standards protocols SOPs GCP and relevant guidelines to meet local regulations Communicating project scope timelines goals technical details and input from the Director Project Manager to the sites throughout the project...

  • Clinical Research Associate

    3 days ago

    Ahmedabad, India CBCC Global Research Full time

    We believe the dedicated people who work at CBCC are the best. They each have deep compassion and a single focus on the well-being of our patients (Job code: CBCCIND/CO/CRA) Work Experience: 4-8 Years Work Location: Ahmedabad, Mumbai, Bangalore, Hyderabad, Pune or Delhi Pre-Requisite Skills: onsite monitoring experience mandatory Job Requirements: -...

  • Study Physician

    2 days ago

    Ahmedabad, Gandhinagar, India Brillex Clinical Research Pvt. Ltd. Full time ₹ 8,00,000 - ₹ 25,00,000 per year

    Role & responsibilitiesPreferred candidate profileq Act as a Study Physician/Co-investigatorq Prepare and review protocols for clinical studiesq Co-ordinate activities related to IECq Communicate IEC related issues to all concernedq Ensure compliance to protocol, SOPs and Regulatory requirementsq Monitor and co-ordinate for volunteer recruitment and...

  • Clinical Research Associate

    3 days ago

    Ahmedabad, Gujarat, India CBCC Global Research Full time

    (Job code: CBCCIND/CO/CRA) Work Experience: 4-8 Years Work Location: Ahmedabad, Mumbai, Bangalore, Hyderabad, Pune or Delhi Pre-Requisite Skills: onsite monitoring experience mandatory Job Requirements: - Key Responsibilities - Overall site management of clinical trials - Ensure effective communication to sites - Prepare for site visits - Assist PM in...