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Project Manager (FSP), Remote (US)

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<strong>Work Schedule<br><br></strong>Standard (Mon-Fri)<br><br><strong>Environmental Conditions<br><br></strong>Office<br><br><strong>MUST HAVE 4+ YEARS OF GLOBAL LEAD PM EXPERIENCE<br><br></strong><strong>Must Have Strong Vendor Management Experience<br><br></strong><strong>MUST BE ABLE TO WORK WELL UNDER PRESSURE FOR HIGH VISIBILITY STUDY<br><br></strong><strong>OBJECTIVES: <br><br></strong>Lead or support study operational strategy and planning and oversee execution of select clinical studies (global/regional and/or local country) for assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.<br><br><ul><li>Support or oversee the execution of select complex study/ies in assigned clinical program(s) in compliance with quality standards on schedule and on budget.</li><li>Oversee Strategic Partners and/or other CROs and other vendors to meet client’s obligations described in ICH-GCP and client’s business objectives.<br><br></li></ul>Studies may include but are not limited to PTA (Post Trial Access), RATIO (R&D Asset Transition and Integration Office), those in wind down, etc. More than one study and/or more than one program may be assigned.<br><br><strong>ACCOUNTABILITIES: <br><br></strong><ul><li>Accountable for planning and operational strategy and execution for assigned clinical trials</li><ul><li>Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents</li><li>Challenges study team to ensure operational feasibility, inclusive of patient and site burden</li><li>Supports budget development and ensures impacts are adequately addressed</li><li>Participates in country and site feasibility/selection process, with a focus on providing country insights, alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy</li><li>Develops and manages study timelines</li><li>Challenges study team to ensure timelines meet the needs of the clinical development plan</li><li>Ensures new team members and vendors are appropriately onboarded</li><li>Identifies and oversees trial risk and mitigation</li><li>Leader of the cross functional study team</li></ul><li>During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place</li><li>Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly</li><li>Supports/reviews study budget planning and management and accountable for external spend related to study execution. Works closely with COM (if applicable) and COPL, Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to COM and COPL; serve as escalation point for all vendors managed by Strategic Partner and/or other CROs</li><li>Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted;</li><li>Specific areas of sponsor oversight include, but are not limited to:</li><ul><li>Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring</li><li>Conduct Oversight Monitoring Visits, as applicable</li><li>Review and endorsement of relevant study plans, as applicable</li><li>Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes</li><li>Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study</li><li>Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies</li><li>Review and ownership of trial operational data (e.g. CTMS)</li><li>Review and provide oversight of internal trial reports</li></ul><li>In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR. </li><li>Support data review for database lock and CSR writing and review (including appendices)</li><li>Collect/review/File study documents in support of the trial master file (TMF) </li><li>Collect/review/File study documents in support of the regulatory filing</li><li>Responsible for overseeing study financial reconciliation</li><li>Ensure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.</li><li>Site relationship management</li><li>Review and provide oversight of trial audits</li><li>Proper and timely follow up to audit findings and CAPAs</li><li>Preparation for Agency inspections, including document readiness, tracking, storyboard development and other pertinent documents and preparations<br><br></li></ul><strong>Skills: <br><br></strong><ul><li>Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.</li><li>Demonstrated successful experience in project/program management and matrix leadership</li><ul><li>E.g. timeline/budget management</li><li>E.g. Risk identification and management</li></ul><li>Works independently and is highly organized</li><li>Good communication skills</li><li>Excellent teamwork, organizational, interpersonal, and problem-solving skills, including successful experience with Leading cross-functional teams, vendor selection and oversight</li><li>Demonstrated successful experience managing recruitment challenges and boosting enrollment</li><li>Fluent business English (oral and written)<br><br></li></ul><strong>Experience: 6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA). Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.<br><br></strong>

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

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10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...

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