Site Activation Manager

2 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 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.

Key Requirements:

  1. Bachelor's Degree Life sciences or related field.
  2. Associate Site Activation Manager: 3 to 5 years of regional experience in clinical research environment, ideally regulatory and study start-up capacity.
  3. Site Activation Manager: Over 5 years of regional experience in clinical research environment, ideally regulatory and study start-up capacity.
  4. Strong negotiation and communication skills with ability to challenge.
  5. Excellent interpersonal skills and strong team player.
  6. Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects.
  7. Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process.
  8. Demonstrated proficiency in using systems and technology to achieve work objectives.
  9. Good regulatory and/or technical writing skills.
  10. Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines.
  11. Good leadership skills, with ability to motivate, coach and mentor.
  12. Good organizational and planning skills.
  13. Ability to exercise independent judgment taking calculated risks when making decisions.
  14. Good presentation skills.
  15. Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
  16. Excellent understanding of study financial management.
  17. Proven ability to work on multiple projects balancing competing priorities.

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.

Learn more at https://jobs.iqvia.com

#J-18808-Ljbffr

  • Site Engineering Manager

    3 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia SPECIFIC DIMENSION SDN BHD Full time

    Job OverviewWe are seeking a highly skilled Site Engineer to join our team at SPECIFIC DIMENSION SDN BHD. As a Site Engineer, you will be responsible for overseeing the execution of construction projects, ensuring timely completion and quality delivery.ResponsibilitiesProject Planning and Execution: Develop and implement project plans, schedules, and budgets...

  • Clinical Study Activation Specialist

    2 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia IQVIA Argentina Full time

    Job DescriptionIQVIA 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...

  • Activation Manager

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Dentsu Aegis Network Ltd. Full time

    About Dentsu Aegis Network Ltd.Dentsu Aegis Network Ltd. is a global media agency network that helps clients achieve their marketing goals through integrated communications, media, and digital services. With a presence in over 145 countries and regions, our network encompasses five leadership brands—Carat, dentsu X, iProspect, Dentsu Creative, and...

  • Site Quality Assurance Manager

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Aurora Talent Full time

    Job OverviewAurora Talent, a leading talent acquisition and advisory services provider, is seeking a seasoned Site Quality Coordinator to join their team. This exciting opportunity involves independently managing all aspects of Quality Assurance (QA) activities across relevant disciplines at the yards.The successful candidate will possess comprehensive...

  • Site Management Specialist

    1 day ago

    Kuala Lumpur, Kuala Lumpur, Malaysia China Construction Development (Malaysia) Sdn Bhd Full time

    Job OverviewWe are looking for a skilled Site Management Specialist to join our team. The successful candidate will be responsible for managing project site activities and ensuring that all work carried out is in accordance with the drawings, specifications, construction plan, procedures, work instructions, and others.Key Responsibilities:To analyze and...

  • Manager, Activation

    4 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia AEON Credit Service (M) Berhad Full time

    This job is for a Manager of Activation & Retail Marketing. You might like this job because you'll lead marketing activities, create impactful materials, and optimize retail marketing initiatives for growth and profit.ResponsibilitiesLead the execution of marketing activities for the assigned portfolio to achieve growth opportunities, market share and profit...

  • Activation Manager

    4 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia AEON Credit Service (M) Berhad Full time

    About the RoleThis is an exciting opportunity for a Brand Positioning Specialist to join AEON Credit Service (M) Berhad and contribute to the company's success by creating impactful marketing and trade marketing materials. The ideal candidate will have experience in the financial or banking industry and possess sound marketing knowledge.Key...

  • Site Quality Coordinator

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Aurora Talent Full time

    Direct message the job poster from Aurora TalentSenior Recruitment Consultant - APAC | Connecting Industry Experts Hiring for Power & Renewables | Oil and GasAurora Talent has a proven track record in recruiting exceptional leaders from diverse backgrounds. Our specialized divisions offer world-class talent acquisition and advisory services, covering...

  • Site Management Specialist

    4 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Parexel Full time

    We are seeking a highly skilled Clinical Research Associate to join our team.Job OverviewAs a Clinical Research Associate, you will be responsible for managing clinical trials from site identification 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...

  • Brand Activation Manager

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia AEON Credit Service (M) Berhad Full time

    AEON Credit Service (M) Berhad seeks a Brand Activation Manager to lead marketing activities and create impactful materials for growth and profit.ResponsibilitiesLead the execution of marketing strategies to achieve growth opportunities, market share, and profit objectives in line with commercial priorities.In charge of planning and implementing brand...

  • Senior Activation Manager

    6 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Absolutemkt Full time

    About This RoleThis exciting opportunity is a Senior Activation position within our esteemed organization. As part of our Activation & Planning team, you will play a pivotal role in driving business growth and enhancing client success.The ideal candidate will have a proven track record in account management, with expertise in ATL, BTL, Digital, Social, and...

  • Site Operations Coordinator

    1 day ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Perdana ParkCity Sdn Bhd Full time

    About the RoleWe are looking for a Site Operations Coordinator to join our team at Perdana ParkCity Sdn Bhd. The successful candidate will have a minimum Certificate / Diploma in Engineering in Civil & Structural or Civil Engineering and a minimum of 5 years of experience in site supervision with a property developer or contractor.The ideal candidate will be...

  • Site Initiation and Maintenance Lead

    2 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia IQVIA Argentina Full time

    Job DescriptionThe Regulatory Operations Manager will be responsible for ensuring the smooth operation of regulatory activities for clinical studies. This includes overseeing the execution of site activation and maintenance activities, developing and implementing management plans, and collaborating with regulatory and site activation...

  • Site Operations Coordinator

    1 day ago

    Kuala Lumpur, Kuala Lumpur, Malaysia JAC Recruitment Full time

    Key ResponsibilitiesThe successful candidate will be responsible for:Providing expert advice on Civil, Structure, and Architecture aspects to the Project Manager.Ensuring the project is completed safely, on time, and within budget.Coordinating all site works activities related to CSA.Assisting in creating work method statements and safe operating procedures...

  • Project Site Engineer

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia SPECIFIC DIMENSION SDN BHD Full time

    Job OverviewSPECIFIC DIMENSION SDN BHD is seeking a highly skilled Project Site Engineer to lead our project activities. The ideal candidate will have experience in managing engineering projects and ensuring timely completion.Key ResponsibilitiesProject Planning and ExecutionSite Inspection and Quality ControlTeam Management and CoordinationReporting and...

  • Addressable Activation Executive

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Dentsu Aegis Network Ltd. Full time

    About the RoleWe're seeking an experienced professional to join our team as a Manager of Ad Solutions. As a key member of our team, you will be responsible for leading and managing the implementation and execution of Ad Ops strategies and day-to-day client communication to achieve their goals.Our team works closely with clients to deliver innovative...

  • Technical Site Manager

    4 hours ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Google Full time

    Job DescriptionAs a Technical Site Manager, you will be responsible for leading a team of Data Center Technicians who install and maintain complex computing infrastructure and network systems.This includes managing daily operations, identifying and resolving technical issues, and developing project contingency plans to ensure optimal system performance.Our...

  • Activation Director

    6 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Absolutemkt Full time

    About AbsolutemktAt Absolutemkt, we are at the forefront of our industry. Our Activation & Planning team is where we make a tangible impact on our clients' businesses.We strive to identify new business opportunities that drive revenue growth and enhance our clients' success.Key Responsibilities:Manage multiple client relationships and develop strong working...

  • Clinical Trials Manager, Site Contracting

    1 day 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,...

  • Site Project Administrator

    1 day ago

    Kuala Lumpur, Kuala Lumpur, Malaysia DK-MY Properties Full time

    ResponsibilitiesThis is an exciting opportunity to join DK-MY Properties as a Clerk of Works. Your key responsibilities will include: Supervising site operations to ensure timely completion without compromising quality or regulations;Managing materials delivery to ensure compliance with approved specifications;Maintaining accurate records of site progress...