Current jobs related to Site Activation Partner - Darwin - Pharmiweb

  • Clinical Study Activation Manager

    2 days ago

    Darwin, Northern Territory, Australia Pharmiweb Full time

    About the RoleWe are seeking a highly skilled and experienced Clinical Study Activation Manager to join our team. As a Clinical Study Activation Manager, you will be responsible for the activation of clinical study sites, ensuring that all necessary documents and materials are in place, and that sites are fully prepared to conduct the study.Key...

  • Project Site Engineer

    2 weeks ago

    Darwin, Northern Territory, Australia Workforce Australia For Individuals Full time

    About Our ClientWorkforce Australia For Individuals is proud to partner with a leading property development and construction company based in Darwin, Northern Territory.About The RoleThe Project Site Engineer will play a crucial role in supporting the coordination of trades and maintaining work quality to meet project goals.Key Responsibilities:Support the...

  • Project Site Engineer

    3 weeks ago

    Darwin, Northern Territory, Australia Workforce Australia For Individuals Full time

    About Our CompanyWorkforce Australia For Individuals is a leading provider of workforce solutions, partnering with clients to deliver high-quality projects in the property development and construction industry.About The RoleWe are seeking a highly skilled and experienced Project Site Engineer to join our team. As a Project Site Engineer, you will play a...

  • Site Manager

    1 week ago

    Darwin, Northern Territory, Australia CoreStaff Full time

    {"title": "Site Supervisor", "description": "About the RoleCoreStaff is seeking a Site Supervisor to join our team in Darwin, Northern Territory. As a Site Supervisor, you will be responsible for coordinating and controlling all physical aspects of construction projects to ensure safety and compliance with regulatory requirements.Key...

  • Project Site Engineer

    3 weeks ago

    Darwin, Northern Territory, Australia Workforce Australia for Individuals Full time

    About Our CompanyWorkforce Australia for Individuals is a leading provider of workforce solutions, partnering with clients to deliver high-quality projects.About The RoleWe are seeking a highly skilled Project Site Engineer to join our team. As a Project Site Engineer, you will play a critical role in supporting the coordination of trades and maintaining...

  • Site Identification Lead

    2 days ago

    Darwin, Australia Pharmiweb Full time

    Site Identification Lead ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Site ID LeadBased anywhere EU - home or office basedAt ICON, it’s our...

  • Project Site Engineer

    2 weeks ago

    Darwin, Northern Territory, Australia CoreStaff Full time

    {"title": "Project Site Engineer", "subtitle": "Join CoreStaff in Darwin, NT", "content": "CoreStaff is seeking a highly skilled Project Site Engineer to join our team in Darwin, Northern Territory. As a key member of our project team, you will be responsible for ensuring the successful delivery of our construction projects.Key Responsibilities:Coordinate...

  • Site Healthcare Specialist

    2 weeks ago

    Darwin, Northern Territory, Australia ASPEN MEDICAL Full time

    Job Title: Site MedicWe are seeking a highly skilled and experienced Registered Nurse or Paramedic to join our team as a Site Medic. This is a fixed-term opportunity working on a night shift/day shift basis, commencing after credentialing and onboarding.Key Responsibilities:Providing initial emergency response and ensuring medications, including restricted...

  • Construction Site Supervisor

    2 days ago

    Darwin, Northern Territory, Australia CoreStaff Full time

    About the RoleCoreStaff is seeking a skilled Site Supervisor to join our team in Darwin, Northern Territory. As a Site Supervisor, you will be responsible for coordinating and controlling all physical aspects of construction projects to ensure safety and compliance with regulatory requirements.Key Responsibilities:Coordinate and control construction...

  • Site Engineer

    3 weeks ago

    Darwin, Northern Territory, Australia Clough Full time

    Unlock a Challenging and Rewarding Career OpportunityClough, a pioneering project delivery company, is seeking experienced Site, Project, and Senior Project Engineers to join our growing project team.About the RoleWe are currently seeking talented individuals to leverage their experience in piling, dredging, earthworks, pavements, services, and/or...

  • Project Site Engineer

    5 days ago

    Darwin, Northern Territory, Australia CoreStaff Full time

    About the RoleCoreStaff is seeking a highly skilled Project Site Engineer to join our team in Darwin, Northern Territory. As a key member of our project team, you will be responsible for ensuring the successful delivery of our construction projects.Key ResponsibilitiesCoordinate onsite activities and ensure high standards of quality are maintainedManage the...

  • Construction Site Manager

    3 weeks ago

    Darwin, Northern Territory, Australia CoreStaff Full time

    **About the Role**CoreStaff is seeking a highly skilled and experienced Site Supervisor to join our team in Darwin, Northern Territory. As a Site Supervisor, you will be responsible for coordinating and controlling all physical aspects of construction projects to ensure safety and compliance with regulatory requirements.**Key Responsibilities:**Coordinate...

  • Construction Site Manager

    2 weeks ago

    Darwin, Northern Territory, Australia CoreStaff Full time

    **About the Role**CoreStaff is seeking a highly skilled and experienced Site Supervisor to join our team in Darwin, Northern Territory. As a Site Supervisor, you will be responsible for coordinating and controlling all physical aspects of construction projects to ensure safety and compliance with regulatory requirements.**Key Responsibilities:**Coordinate...

  • Construction Site Manager

    5 days ago

    Darwin, Northern Territory, Australia CoreStaff Full time

    About the RoleCoreStaff is seeking a skilled Site Supervisor to join our team in Darwin, Northern Territory. As a Site Supervisor, you will be responsible for coordinating and controlling all physical aspects of construction projects to ensure safety and compliance with regulatory requirements.Key ResponsibilitiesCoordinate and control construction...

  • Project Site Engineer

    1 day ago

    Darwin, Northern Territory, Australia CoreStaff Full time

    About the RoleCoreStaff is seeking a highly skilled Project Site Engineer to join our team in Darwin, Northern Territory. As a Project Site Engineer, you will play a crucial role in supporting the coordination of trades and maintaining work quality to meet project goals.Key ResponsibilitiesAssist with the coordination of onsite activities and day-to-day...

  • Site Operations Manager

    2 weeks ago

    Darwin, Northern Territory, Australia BMD Group Full time

    {"title": "Site Engineer Role at BMD Group", "description": "Key ResponsibilitiesWe are seeking an experienced Site Engineer to join our team at BMD Group. As a Site Engineer, you will be responsible for:Leading a team of Site Engineers and Graduates to achieve innovative solutions to complex challengesCollaborating with subcontractors to ensure timely...

  • Project Site Engineer

    1 week ago

    Darwin, Northern Territory, Australia CoreStaff Full time

    About the RoleCoreStaff is seeking a highly skilled Project Site Engineer to join our team in Darwin, Northern Territory. As a key member of our project team, you will be responsible for ensuring the successful delivery of our construction projects.Key ResponsibilitiesCoordinate onsite activities and ensure high standards of quality are maintainedManage the...

  • Construction Site Manager

    3 weeks ago

    Darwin, Northern Territory, Australia CoreStaff Full time

    **About the Role**CoreStaff is seeking a highly skilled and experienced Site Supervisor to join our team in Darwin, Northern Territory. As a Site Supervisor, you will be responsible for coordinating and controlling all physical aspects of construction projects to ensure safety and compliance with regulatory requirements.**Key Responsibilities:**Coordinate...

  • Activity Coordinator

    4 days ago

    Darwin city centre, Northern Territory, Australia ALPA Full time

    Make a Difference in Remote Aboriginal CommunitiesWe are seeking a dedicated and passionate Activity Coordinator to join our team at ALPA. As an Activity Coordinator, you will play a vital role in coordinating meaningful and engaging activities that promote cultural exchange and community development in remote Aboriginal communities.About the RoleCoordinate...

  • Site Operations Manager

    3 weeks ago

    Darwin, Northern Territory, Australia MCMAHON SERVICES Full time

    About UsMcMahon Services is a leading construction services and environmental contractor with over 25 years of experience delivering complex projects across the Northern Territory.We have grown into an industry-leading contractor, delivering challenging defence projects in partnership with Tier 1 customers.As a result of our strategic growth and project...

Site Activation Partner

3 months ago

Darwin, Australia Pharmiweb Full time
Description

Site Activation Partner (CMA) with experience in start-up for USA and Canada assigned to client Home Based

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health
  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

Job responsibilities
• Performs remote site qualification, site initiation, site monitoring calls, and close-out visits ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. May require knowledge of Good Pharmacoepidemiology Practices (GPP) and Good Epidemiologic Practices (GEP) guidelines for NIS and to adhere to a schedule of data collection from HCPs and patients for NIS, effectively employing technology for tracking.
• Assesses the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Applies query resolution techniques remotely and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Assesses site compliance with electronic data capture requirements.
• May perform Remote Aggregated Data Review (RADaR) utilizing the appropriate tools to identify, respond and manage issues in line with the associated Work Instructions (WI), RADaR guideline and Clinical Monitoring Plan (CMP)/Site Management Plan (SMP) for assigned sites/project. Ability to identify trends within and across sites, escalating issues and trends to develop corrective actions / preventative actions.
• May assesses if investigational product (IP) has been dispensed and administered to subjects/patients according to the protocol, identifying if issues or risks associated with blinded or randomized information related to IP have occurred. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely reviews the site section of the TMF or project master file (PMF) in totality for accuracy, timeliness and completeness. Requests new/updated documents from the site, as required. If remote access is available to an electronic Investigator Site File (eISF), routinely reviews the eISF for accuracy, timeliness and completeness. Reconciles contents of the eISF with the trial master file (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations..
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and CMP/SMP Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
• Acts as primary liaison with project site personnel or NIS reporters, in collaboration with the on-site CRA. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings, Advisory Committee Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• For Real World and Late Phase, the CMA II may be assigned to the Registry Coordinating Center (RCC). Additional responsibilities include:
o Data review, data query resolution and direct data entry of Health Care Provider (HCP) and Patient information.
o Call center-based communications (inbound and outbound) with registry physicians, and/or patients, by utilizing web-based tools and other communication tools to ensure compliance with protocol requirements and relevant guidelines
o Complete chart abstraction activities
o Provide training to junior staff
o Consult with RWLP Regulatory Advisory Services to maintain current information of local and regional requirements for real world and late phase study designs.

Qualifications

What we’re looking for
• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and/or other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies. Proficiency in navigation within CTMS systems and Data Platforms for projects required
• Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected

* Experience in MoH US: FDAMoH Canada: Health Canada / SIP: Shared Investigator Portal

Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health

#LI-RR1