Clinical Study Activation Specialist

3 days ago

Kuala Lumpur, Kuala Lumpur, Malaysia IQVIA Argentina Full time
Job Description

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

About the Role

We are seeking an experienced Site Activation Manager to join our team in Argentina. As a Site Activation Manager, you will be responsible for directing and managing the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

Key Responsibilities:

  1. Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
  2. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
  3. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
  4. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
  5. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
  6. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
  7. Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
  8. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
  9. Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).
  10. Mentor and coach colleagues as required.
  11. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
  12. May take a lead role in developing long standing relationships with preferred IQVIA customers.
  13. Deliver presentations/training to clients, colleagues and professional bodies, as required.
  14. May be involved in activities related to monthly study budget planning and reviews.

About You

To be successful in this role, you will require a Bachelor's Degree in Life Sciences or a related field, and a minimum of 3-5 years' experience in a clinical research environment, preferably with regulatory and study start-up capacity. Strong negotiation and communication skills, excellent interpersonal skills and a proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects are also essential. You will also possess a thorough understanding of regulated clinical trial environments and in-depth knowledge of drug development processes. Proficiency in using systems and technology to achieve work objectives, good regulatory and/or technical writing skills and strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines are also required. Additionally, you should have good leadership skills, with the ability to motivate, coach and mentor, as well as excellent organizational and planning skills and the ability to exercise independent judgment taking calculated risks when making decisions.

About IQVIA

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

  • Site Activation Manager

    3 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia IQVIA Argentina Full time

    IQVIA is looking to appoint a Site Activation Manager to be part of our clinical Functional Service Provider (cFSP) team. You will direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and...

  • Study Management Coordinator

    3 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia IQVIA Argentina Full time

    Job SummaryThe Site Activation Manager will oversee the execution of site activation and maintenance activities for selected studies or multi-protocol programs. This includes developing and implementing management plans, collaborating with regulatory and site activation teams, and preparing and reviewing technical and administrative documentation.Key...

  • Research Study Coordinator Lead

    7 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    Job SummaryThe Clinical Trial Administrator is responsible for performing study-related tasks and ensuring timely production of high-quality clinical data. This individual will work closely with the project team to ensure successful execution of clinical research projects.Main Duties:Document and track study activities using relevant forms and tools.Assist...

  • Clinical Trial Coordinator Specialist

    4 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    Job Overview:The Clinical Trial Administrator (CTA) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. This position requires strong organizational and communication skills to ensure timely production of high-quality clinical data.Key Responsibilities:Document and track study activities using...

  • Clinical Project Coordinator Specialist

    7 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia PSI CRO AG Full time

    Job OpportunityWe're searching for a qualified Research Associate to oversee the clinical aspects of global projects in Malaysia.About the Position:Manage the clinical aspects of full-service global projects in Malaysia.Supervise study activities, timelines, milestones, and schedules on the country level.Conduct and report all types of onsite monitoring...

  • Clinical Trial Project Coordinator

    7 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    Job OverviewThe Clinical Trial Administrator plays a vital role in the execution of clinical research projects. As an essential member of a Clinical Project Team, this individual will be responsible for performing study-related tasks and ensuring timely production of high-quality clinical data.Main Responsibilities:Document and track study activities using...

  • Clinical Study Coordinator

    4 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    Summary of Responsibilities:Assist in setting up and maintaining tracking systems/spreadsheets for study supplies.Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and archive as applicable.Audit and CAPA tracking.Liaise with vendors, as needed, for study conduct such as printing study...

  • Clinical Monitoring Lead

    3 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    **Job Description:**We are seeking an experienced Clinical Research Associate II to conduct site monitoring responsibilities for clinical trials. The ideal candidate will have excellent communication skills and be able to work effectively in a matrix environment.Key Responsibilities:Study Coordination:Coordinate study activities with study staff and ensure...

  • Clinical Project Lead

    7 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Psi CRO Ag Full time

    We are a dynamic and global Contract Research Organization (CRO) committed to delivering high-quality clinical research services. Our company has grown organically from a handful of countries to a global presence, while maintaining our independence and freedom to operate.Job RequirementsWe are looking for a knowledgeable and team-oriented Senior Clinical...

  • Senior Clinical Trial Coordinator

    3 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    **Job Summary:**Fortrea is seeking an experienced Clinical Research Associate II to conduct site monitoring responsibilities for clinical trials. The ideal candidate will have a thorough understanding of ICH GCP Guidelines and local regulatory requirements.Key Responsibilities:Study Coordination:Coordinate study activities with study staff and ensure...

  • Senior Clinical Trial Manager

    7 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia PSI CRO AG Full time

    Job OverviewWe are looking for a skilled Clinical Research Associate to join our team in Malaysia.The successful candidate will be responsible for managing the clinical aspects of full-service global projects.Main Responsibilities:Supervise study activities, timelines, milestones, and schedules on the country level.Conduct and report all types of onsite...

  • Clinical Research Associate II Specialist

    3 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    **Job Description:**We are seeking a highly motivated and experienced Clinical Research Associate II to join our team at Fortrea. The successful candidate will be responsible for conducting site monitoring responsibilities for clinical trials, ensuring the protection of subjects, and safeguarding data integrity.Key Responsibilities:Site Management:Verify...

  • Clinical Trials Coordinator

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Parexel Full time

    In this role, you will play a critical part in the success of our clinical trials.Job DescriptionAs a Clinical Research Associate, you will be responsible for managing clinical trials from start-up to close out.You will work closely with investigators and site staff to ensure that studies are implemented according to protocol.You will assess and ensure...

  • Senior Clinical Contracts Lead

    2 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Syneos Health, Inc. Full time

    Job OverviewSyneos Health is a leading integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our team of experts translates unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.We are seeking a seasoned Clinical Contracts Lead to join our dynamic team. This key...

  • Global Clinical Research Associate Lead

    7 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia PSI CRO AG Full time

    Job DescriptionWe're seeking an experienced Senior Clinical Research Associate to manage the clinical aspects of full-service global projects in Malaysia.About the Role:Supervise study activities, timelines, milestones, and schedules on the country level.Conduct and report all types of onsite monitoring visits.Be involved in study set-up, including site...

  • Clinical Research Associate II

    3 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    Clinical Research Associate II (CRA II)Apply locations Kuala Lumpur time type Full time posted on Posted Yesterday job requisition id 251235Summary of Responsibilities:Site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including...

  • Clinical Practice Manager

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia GREAT EASTERN Full time

    We are seeking a Clinical Practice Manager to join our team.**Job Summary:**To lead the development and management of the panel clinic network by leveraging medical expertise to ensure quality and cost-effective healthcare services.The role requires a deep understanding of primary care settings, medical cost structures, clinical best practices, and the...

  • Clinical Trials Manager, Site Contracting

    2 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Syneos Health, Inc. Full time

    About Syneos HealthSyneos Health is a leading integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our team of experts translates unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.We are seeking a highly motivated and experienced Clinical Trials Manager,...

  • Brand Activation Specialist

    9 hours ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Pentavite Malaysia Sdn Bhd Full time

    Pentavite Malaysia Sdn Bhd is seeking a highly skilled Brand Activation Specialist - In-Store Promotions to join our team. This role will be responsible for coordinating with the operation team on overall outlet improvement and implementation of go-to-market plans, as well as working closely with the brand marketing team to develop impactful branding...

  • Clinical Training Specialist

    3 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Rhian_Convatec Full time

    About UsRhian_Convatec is a pioneering medical technology company dedicated to improving the lives we touch. Our focus is on delivering innovative solutions for the management of chronic conditions.We operate globally, providing our products and services in almost 100 countries. With a team of around 10,000 colleagues, we are committed to being forever...