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Thermo Fisher Scientific · Australia · Remote

Sub-Saharan Africa

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Sub-Saharan Africa
Sub-Saharan AfricaWork ScheduleSub-Saharan Africa

Sub-Saharan AfricaOtherSub-Saharan Africa

Sub-Saharan AfricaEnvironmental ConditionsSub-Saharan Africa

Sub-Saharan AfricaOfficeSub-Saharan Africa

Sub-Saharan AfricaAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.Sub-Saharan Africa

Sub-Saharan AfricaOur global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.Sub-Saharan Africa

Sub-Saharan AfricaDiscover Impactful Work:Sub-Saharan Africa

Sub-Saharan AfricaPerforms and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.Sub-Saharan Africa

Sub-Saharan AfricaA day in the Life:Sub-Saharan Africa

  • Sub-Saharan AfricaMonitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicableSub-Saharan Africa
  • Sub-Saharan AfricaProvides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.Sub-Saharan Africa
  • Sub-Saharan AfricaParticipates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.Sub-Saharan Africa
  • Sub-Saharan AfricaEnsures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.Sub-Saharan Africa
  • Sub-Saharan AfricaContributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).Sub-Saharan Africa
  • Sub-Saharan AfricaFacilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.Sub-Saharan Africa
  • Sub-Saharan AfricaResponds to company, client and applicable regulatory requirements/audits/inspections.Sub-Saharan Africa
  • Sub-Saharan AfricaMaintains & completes administrative tasks such as expense reports and timesheets in a timely manner.Sub-Saharan Africa
  • Sub-Saharan AfricaContributes to other project work and initiatives for process improvement, as required.Sub-Saharan Africa

Sub-Saharan AfricaKeys to Success:Sub-Saharan Africa

Sub-Saharan AfricaEducationSub-Saharan Africa

  • Sub-Saharan AfricaBachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.Sub-Saharan Africa

Sub-Saharan AfricaExperienceSub-Saharan Africa

  • Sub-Saharan AfricaPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).Sub-Saharan Africa
  • Sub-Saharan AfricaValid driver's license where applicable.

Sub-Saharan AfricaKnowledge, Skills And AbilitiesSub-Saharan Africa

  • Sub-Saharan AfricaEffective clinical monitoring skillsSub-Saharan Africa
  • Sub-Saharan AfricaDemonstrated understanding of medical/therapeutic area knowledge and medical terminologySub-Saharan Africa
  • Sub-Saharan AfricaExcellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documentsSub-Saharan Africa
  • Sub-Saharan AfricaWell-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solvingSub-Saharan Africa
  • Sub-Saharan AfricaAbility to manages Risk Based Monitoring concepts and processesSub-Saharan Africa
  • Sub-Saharan AfricaEffective oral and written communication skills, with the ability to communicate effectively with medical personnelSub-Saharan Africa
  • Sub-Saharan AfricaAbility to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issuesSub-Saharan Africa
  • Sub-Saharan AfricaEffective interpersonal skillsSub-Saharan Africa
  • Sub-Saharan AfricaStrong attention to detailSub-Saharan Africa
  • Sub-Saharan AfricaEffective organizational and time management skillsSub-Saharan Africa
  • Sub-Saharan AfricaAbility to remain flexible and adaptable in a wide range of scenariosSub-Saharan Africa
  • Sub-Saharan AfricaAbility to work in a team or independently as requiredSub-Saharan Africa
  • Sub-Saharan AfricaGood computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate softwareSub-Saharan Africa
  • Sub-Saharan AfricaGood English language and grammar skillsSub-Saharan Africa
  • Sub-Saharan AfricaGood presentation skillsSub-Saharan Africa

Sub-Saharan AfricaWork EnvironmentSub-Saharan Africa

Sub-Saharan AfricaThermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:Sub-Saharan Africa

  • Sub-Saharan AfricaAble to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Sub-Saharan Africa
  • Sub-Saharan AfricaAble to work upright and stationary for typical working hours.Sub-Saharan Africa
  • Sub-Saharan AfricaAble to work in non-traditional work environments.Sub-Saharan Africa
  • Sub-Saharan AfricaAble to use and learn standard office equipment and technology with proficiency.Sub-Saharan Africa
  • Sub-Saharan AfricaAble to perform successfully under pressure while prioritizing and handling multiple projects or activities.Sub-Saharan Africa
  • Sub-Saharan AfricaMay have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.Sub-Saharan Africa
  • Sub-Saharan AfricaThis role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.Sub-Saharan Africa
  • Sub-Saharan AfricaThis position requires overnight travel either regionally or nationally, dependent on business needs.Sub-Saharan Africa
  • Sub-Saharan AfricaAs a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.Sub-Saharan Africa

Sub-Saharan AfricaLocation/Division Specific InformationSub-Saharan Africa

Sub-Saharan AfricaPerforms and coordinates different aspects of the clinical monitoring and site management process. This home-based position requires candidates to currently live in one of the following cities: Brisbane, Adelaide, Perth, Sydney or Melbourne.Sub-Saharan Africa

Sub-Saharan AfricaApply today! Sub-Saharan Africahttp://jobs.thermofisher.comSub-Saharan Africa

Sub-Saharan AfricaThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Sub-Saharan Africa

Sub-Saharan AfricaOur Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Sub-Saharan Africa

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