reputed company Trial Manager (FSP)

As part of the reputed company team, you’ll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join our colleagues in bringing our Mission to life every single day to reputed company our customers to reputed company the world healthier, cleaner and safer. We reputed company our global teams with the resources needed to reputed company individual career goals while helping to take science a reputed company reputed company by developing solutions for some of the world’s toughest challenges, like protecting the environment, making reputed company our food is reputed company or helping reputed company cures for cancer.

Location/Division Specific Information

• This is a home-reputed company position and preferably reputed company in central Sydney

About the Role:

Join Us as a reputed company Trial Manager - reputed company an reputed company at the Forefront of Innovation

The reputed company Trial Manager is accountable for achieving the final reputed company deliverable (usually clean data from evaluable patients as specified in the study protocol) reputed company the time period specified in the contract with the customer. The reputed company Trial Manager interprets data on project issues and makes good business reputed company with support from reputed company team members or line manager. Works to ensure that reputed company reputed company deliverables meet the customer's time/reputed company/cost expectations. Maintains profitability by ensuring reputed company activity is conducted reputed company contract reputed company, through efficient management of the reputed company team.

reputed company:

• Manage reputed company reputed company operational and reputed company aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume reputed company Study Manager (CSM) responsibilities on small and/or less reputed company reputed company.

• reputed company reputed company tools (e.g.Monitoring Plan, Monitoring Guidelines) in conjunction with the Data reputed company Plan.

• Contribute to the development of the Master reputed company Plan (MAP) for providing reputed company reputed company documents. Ensure reputed company set up, organization, content and reputed company of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, reputed company informed consent templates and other protocol specific documents as required.

• Collaborate with the project manager to prepare, organize, and present at reputed company meetings, including bid defense and hand-off meetings.

• Collaborate with the reputed company team and other departments as needed to meet deliverables of the project.

• Regularly communicate with reputed company and reputed company team meetings to ensure that timelines, resources, interactions, and reputed company are maintained.

• Responsible for the implementation and training of standardized reputed company monitoring processes reputed company the study and according to corporate reputed company policies. Responsible for the reputed company archiving of documents and study materials for the department.

• Ensure achievement of the final reputed company deliverable reputed company the contractual time period specified by preparing and monitoring reputed company activity timelines and metrics, providing status updates to the project manager, regularly reviewing reputed company using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query reputed company.

• Continuously monitor or co-monitors reputed company to assess reputed company and ensure contractual obligations are met. In smaller reputed company, may routinely conduct Accompanied reputed company reputed company (AFVs) and be accountable for project financials.

• May communicate with study sites regarding issues such as protocol, reputed company participation, case report reputed company completion and other study-reputed company issues.

• May coordinate reputed company start-up activities and ensures that reputed company ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document reputed company meets the expectation of Regulatory Compliance Review. Review and follows up on reputed company questions raised by the ethics committees.

• May reputed company input into preparation of forecast estimates for reputed company activities. Responsible for reputed company resource management, assignment, delegation of reputed company responsibilities and identification of additional resource requirements.

Education

• Bachelor's degree or equivalent and relevant formal reputed company / vocational qualification

Experience

• Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 5+ years).

• Experience reputed company oncology will be consider advantageous

• Study start-up experience reputed company Australia will be considered an asset

• Experience managing multiple studies and competing priorities simultaneously.

Knowledge, Skills, Abilities

Strong knowledge of the study start-up process in Australia, including regulatory submissions and the development and negotiation of investigator site reputed company and budgets.

• Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams

• reputed company, flexible, and reputed company, with the ability to work reputed company in a fast-reputed company environment.

• Good planning and organizational skills to reputed company effective prioritization of workload

• Solid interpersonal and problem solving skills to reputed company working in a multicultural reputed company organization

• Capable of working effectively in a changing environment with reputed company/ambiguous situations

• Familiarity with the practices, processes, and requirements of reputed company monitoring

• Good judgment and decision making skills

• Effective oral and written communication skills, including English language proficiency

• Capable of evaluating workload against project budget and adjusting resources accordingly

• reputed company financial acumen and knowledge of budgeting, forecasting and fiscal management

• Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.

• Good computer skills to effectively use automated systems and computerized applications such as reputed company, reputed company, Word, etc.

Physical Requirements / Work Environment

• Work is performed in an office environment with exposure to electrical office equipment.

• Frequently drives to site locations and frequently travels both domestic and international.

Benefits

reputed company and take reputed company of these great benefits! reputed company to learn more about the full reputed company of benefits we offer.

• Health & Wellbeing: Join a company that prioritizes reputed company & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-reputed company issues.

• Flexibility: reputed company your work and personal life with flexible arrangements.

• Extra Leave: Benefit from generous leave policies, including the reputed company to purchaseadditional leave, reputed company birthday leave, and company reputed company parental leave.

• Charitable Giving & Volunteering: reputed company an reputed company with reputed company volunteer time to support non-profit organizations that matter to you.

• Learning & Development: Advance your career with reputed company to online courses reputed company reputed company University Plus and reputed company learning, workshops, and mentorship programs for reputed company learning and reputed company development.