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Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

We are hiring for a Clinical Trial Manager - Mandarin proficiency required, based in Australia.

Position Summary:

Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.

Essential functions of the job include but are not limited to:

• Primary clinical point of contact with the client
• Collaborate with PM on monthly invoicing and variance management of clinical budget
• Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
• Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings
• Generate potential site list from key stakeholders and drive site feasibility process
• Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment
• Develop and finalize the country recruitment/retention strategy
• Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures
• Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
• Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
• Support in planning and conducting investigator meetings
• Review and/or approve of IP release packages
• Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
• Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
• Generate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
• Responsible for eTMF implementation and management
• Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure
• Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
• Work closely with PM for project-specific resourcing issues
• Escalate pertinent CRA performance and site compliance issues when necessary
• Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
• Manage processes for investigational product (IP) including drug accountability and reconciliation
• When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed
• Supports business development and marketing activities as appropriate
• May negotiate site budget and investigator contract with support from the legal department and/or site contracts group
• May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan
• May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM
• May perform clinical data review of patient profiles, data listings and summary tables, including query generation
• May have line management responsibilities
• May manages workload of supervised staff with continued assessment and adjustment as needed
• Perform other duties as assigned by management

Minimum Required :

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
• Minimum of 5-8 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience. Experience in Phase 1, FIH health-volunteer clinical trials.
• Mandarin language proficient required to support Mandarin-speaking clients.

Other Required:

• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
• Excellent communication and interpersonal skills to effectively interface with others in a team setting
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Ability to travel domestically and internationally including overnight stays

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.

Are you interested in being part of an innovative team that supports Westinghouse’s mission to provide clean energy solutions?

About MISUMI AmericasMISUMI Americas, a division of MISUMI Group, is a leading provider of standard, configurable, and custom manufacturing solutions.

About Us

At Cloudflare, we are on a mission to help build a better Internet. Today the company runs one of the world’s largest networks that powers millions of websites and other Internet properties for customers ranging from individual bloggers to SMBs to Fortune 500 companies. Cloudflare protects and accelerates any Internet application online without adding hardware, installing software, or changing a line of code. Internet properties powered by Cloudflare all have web traffic routed through its intelligent global network, which gets smarter with every request. As a result, they see significant improvement in performance and a decrease in spam and other attacks. Cloudflare was named to Entrepreneur Magazine’s Top Company Cultures list and ranked among the World’s Most Innovative Companies by Fast Company.

At Cloudflare, we’re not looking for people who wait for a polished roadmap; we’re looking for the builders who see the cracks in the Internet that everyone else has simply learned to live with. We value candidates who have the instinct to spot a “normalized” problem and the AI-native curiosity to create a solution using the latest tools. Our culture is built on iteration, leveraging AI to ship faster today to make it better tomorrow, while ensuring that every improvement, no matter how small, is shared across the team to lift everyone up. If you’re the type of person who values curiosity over bureaucracy, and that AI is a partner in solving tough problems to keep the Internet moving forward, you’ll fit right in.

Available Location: Austin, TX

Job Title

Oracle Operations Manager

Role Summary

The Oracle Operations Manager will work with the Oracle IT team to plan, execute operations, and manage enterprise programs to successful completion. Our large-scale programs span multiple quarters and involve IT, various Business Verticals, and Technical Operations teams across the Oracle ecosystem.

You bring a passion for matching complex business needs with technically innovative solutions, and excel at shifting between high-level strategy and technical execution. You are able to implement and drive standardized Oracle operational methodologies to ensure persistent progress. The ideal candidate is flexible and comfortable playing multiple roles—diplomat, moderator, negotiator, and coach - within a large-scale enterprise environment. Combined with deep technical expertise in cloud operations, you have the ability to build trust and strong partnerships with counterparts in Engineering, Development, and Business units.

Role Responsibilities:

• Build bridges across Oracle business units to ensure programs and projects are effectively planned, developed, and deployed with quality and on-time delivery into our production environments.
• Drive the execution of tasks within cross-functional core teams to ensure the success of large-scale initiatives comprising the Oracle operations portfolio.
• Build transparent communication channels to align enterprise stakeholders, IT, and third-party vendors, ensuring executive audiences receive appropriate updates on program status.
• Manage program scope and execution to committed schedules, maintaining reporting for program deliverables across multiple global business units.
• Ensure adherence to Oracle best practices and accountability throughout the program lifecycle when working with external vendors and partners.
• Manage critical path timelines by proactively identifying risks and facilitating the resolution of blockers to ensure the success of enterprise-tier projects.
• Collaborate on internal processes, tools, and workflows across Oracle functions in support of IT governance and standardized project management methodologies.

Role Requirements

Must-Have Skills

• Minimum 5 years’ experience in program and project management
• Minimum 3 years proven experience in leading highly complex, enterprise-wide initiatives.
• Proficient in solutions that service global Finance and enterprise business capabilities.
• Strong technical background in cloud operations to facilitate architecture and integration discussions within an Oracle environment.
• Track record of delivering technical programs through the full end to end program management lifecycle, from conception to usability study.
• Have a balance of people, organizational, and technical skills to deliver and guide decision making without authority.
• Work independently in a dynamic and high-pressure environment with timely delivery despite ambiguous and changing business requirements.
• Strong competency with project management tools (Confluence, JIRA, Smartsheets, etc.) and various methodologies (Waterfall, Scrum, etc).
• Proven ability to clearly and concisely communicate with an executive audience in both written and verbal communications in English (writing sample will be requested).
• Thrive in a fast-paced enterprise environment, with the ability to learn and deploy new Oracle technologies quickly.
• Bachelor’s degree in computer science, Information Systems Management, Technology management, Business management or comparable work experience.

Nice-To-Have Skills

• Direct experience with Oracle implementation and management at an enterprise scale.
• Experience with both waterfall and Agile development methodologies
• PMP/PgMP and Agile certifications
• Familiarity with Oracle-specific governance, risk, and compliance (GRC) frameworks.

What Makes Cloudflare Special?

We’re not just a highly ambitious, large-scale technology company. We’re a highly ambitious, large-scale technology company with a soul. Fundamental to our mission to help build a better Internet is protecting the free and open Internet.

Project Galileo: Since 2014, we’ve equipped more than 2,400 journalism and civil society organizations in 111 countries with powerful tools to defend themselves against attacks that would otherwise censor their work, technology already used by Cloudflare’s enterprise customers–at no cost.

Athenian Project: In 2017, we created the Athenian Project to ensure that state and local governments have the highest level of protection and reliability for free, so that their constituents have access to election information and voter registration. Since the project, we’ve provided services to more than 425 local government election websites in 33 states.

1.1.1.1: We released1.1.1.1 to help fix the foundation of the Internet by building a faster, more secure and privacy-centric public DNS resolver. This is available publicly for everyone to use - it is the first consumer-focused service Cloudflare has ever released. Here’s the deal - we don’t store client IP addresses never, ever. We will continue to abide by our privacy commitment and ensure that no user data is sold to advertisers or used to target consumers.

Sound like something you’d like to be a part of? We’d love to hear from you!

Please note that applicants who progress to the offer stage of the interview process may be asked to attend an in-person interview within one of the Cloudflare Offices or Cloudflare Hubs.  More details about this will be available at that stage of the interview process.

This position may require access to information protected under U.S. export control laws, including the U.S. Export Administration Regulations. Please note that any offer of employment may be conditioned on your authorization to receive software or technology controlled under these U.S. export laws without sponsorship for an export license.

Cloudflare is proud to be an equal opportunity employer.  We are committed to providing equal employment opportunity for all people and place great value in both diversity and inclusiveness.  All qualified applicants will be considered for employment without regard to their, or any other person’s, perceived or actualrace, color, religion, sex, gender, gender identity, gender expression, sexual orientation, national origin, ancestry, citizenship, age, physical or mental disability, medical condition, family care status, or any other basis protected by law. We are an AA/Veterans/Disabled Employer.

Cloudflare provides reasonable accommodations to qualified individuals with disabilities.  Please tell us if you require a reasonable accommodation to apply for a job. Examples of reasonable accommodations include, but are not limited to, changing the application process, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.  If you require a reasonable accommodation to apply for a job, please contact us via e-mail at hr@cloudflare.com or via mail at 101 Townsend St. San Francisco, CA 94107.