Senior Clinical Study Manager

Other Jobs To Apply

<p>Veranex’s mission as an <em>Innovation CRO</em> is to improve patient outcomes by accelerating our clients’ innovations to market.  As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ <em>Vision to Velocity</em> through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. </p><p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="text-decoration: underline; font-family: inter; font-size: 12pt;"><strong>About This Role:</strong></span></p> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: #27251e; font-family: inter; font-size: 12pt;">The <strong>Senior Clinical Study Manager</strong> is responsible for planning, executing, and overseeing clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory standards. This role involves collaborating with various stakeholders, including sponsors and regulatory authorities, to drive the successful completion of clinical studies. By managing the operational aspects of the trial, a Clinical Study Manager ensures that high-quality data is generated, contributing to the advancement of medical science and the development of new therapies.</span></p> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"> </p> <p style="margin: 6pt 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="text-decoration: underline; font-family: inter; font-size: 12pt;"><strong>What You Will Do: </strong></span></p> <p style="line-height: normal; margin: 0in 0in 8pt 0px; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;"><strong>Study Management</strong></span></p> <ul style="margin-bottom: 0in; margin-top: 0px;" type="disc"> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Lead day-to-day management of study activities and deliverables.</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Serve as a liaison with stakeholders across all functional areas of the study.</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Manage study budget and timelines.</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Manage vendors, including the implementation and coordination of vendor scope of work (SOW).</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Serve as a point of contact for issue escalation.</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Interact directly with institutions and investigators, execute clinical research initiatives, and ensure alignment with strategic goals.</span></li> </ul> <p style="line-height: normal; margin: 0in 0in 8pt 0px; font-size: 12pt; font-family: inter;"> </p> <p style="line-height: normal; margin: 0in 0in 8pt 0px; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;"><strong>Study Start-Up, Site Management & Execution</strong></span></p> <ul style="margin-bottom: 0in; margin-top: 0px;" type="disc"> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Coordinate and support execution of study projects, including:</span> <ul style="margin-bottom: 0in; margin-top: 0px;" type="circle"> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Site identification and initiation</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Ethics and regulatory approvals</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Contracting</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Site budgeting and invoicing</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Site staff training</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Site initiations, routine monitoring, and close-out activities</span></li> </ul> </li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Identify and establish the suitability of study investigators and sites and liaise with them to ensure compliance with all study requirements, approvals, and agreements.</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Lead the development and implementation of key study documents, including study-specific plans, monitoring plans, study reference manuals, and source document templates.</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Lead the execution of clinical studies, evaluation and analysis of clinical data, and preparation/review of clinical study reports.</span></li> </ul> <p style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"> </p> <p style="line-height: normal; margin: 0in 0in 8pt 0px; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;"><strong>Quality, Compliance & Oversight</strong></span></p> <ul style="margin-bottom: 0in; margin-top: 0px;" type="disc"> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Oversee maintenance of clinical and regulatory files, ensuring accurate and timely tracking and documentation.</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Oversee the development of clinical reports supporting regulatory submissions.</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Oversee monitoring of study conduct and progress, including proactive identification and resolution of issues impacting quality, timelines, budget, or compliance.</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Identify and mitigate quality risks and/or issues associated with assigned studies and activities.</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Ensure study conduct complies with ethical and regulatory standards, SOPs, GCP, and local regulations.</span></li> </ul> <p style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"> </p> <p style="line-height: normal; margin: 0in 0in 8pt 0px; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;"><strong>Performance Tracking & Reporting</strong></span></p> <ul style="margin-bottom: 0in; margin-top: 0px;" type="disc"> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Lead the collection, tracking, and reporting of key performance indicators (KPIs), including:</span> <ul style="margin-bottom: 0in; margin-top: 0px;" type="circle"> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">query resolution</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">safety data collection/issues</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">product/device reconciliation and shipment</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">site and patient enrollment</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">protocol deviations</span></li> </ul> </li> </ul> <p style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"> </p> <p style="line-height: normal; margin: 0in 0in 8pt 0px; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;"><strong>Strategic & Business Support</strong></span></p> <ul style="margin-bottom: 0in; margin-top: 0px;" type="disc"> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Contribute to business development activities as a subject matter expert (SME).</span></li> <li style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Generate strategy and proposal documentation as directed.</span></li> </ul> <p style="line-height: normal; margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; font-size: 12pt; font-family: inter;"> </p> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="text-decoration: underline; font-family: inter; font-size: 12pt;"><strong>Qualifications</strong></span></p> <p style="margin: 0in 0in 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="font-family: inter; font-size: 12pt;"><strong>Required:</strong></span></p> <ul style="margin-top: 0in; margin-bottom: 0in;" type="disc"> <li style="margin-bottom: 0in; line-height: normal; margin-top: 0in; margin-right: 0in; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Bachelor's degree in health sciences or related discipline</span></li> <li style="margin-bottom: 0in; line-height: normal; margin-top: 0in; margin-right: 0in; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Minimum of 5 years of relevant experience in clinical study planning, preferably within a MedTech-oriented CRO</span></li> <li style="margin-bottom: 0in; line-height: normal; margin-top: 0in; margin-right: 0in; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Experience maintaining documentation in compliance with FDA and ISO standards</span></li> <li style="margin-bottom: 0in; line-height: normal; margin-top: 0in; margin-right: 0in; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Ability to independently manage multiple priorities in a fast-paced environment</span></li> <li style="margin-bottom: 0in; line-height: normal; margin-top: 0in; margin-right: 0in; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Strong organizational, analytical, and problem-solving skills</span></li> <li style="margin-bottom: 0in; line-height: normal; margin-top: 0in; margin-right: 0in; font-size: 12pt; font-family: inter;"><span style="font-family: inter; font-size: 12pt;">Excellent written and verbal communication skill</span></li> </ul><p><em><span style="font-family: Calibri, sans-serif; white-space: normal;"><span style="font-size: medium;">Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy,  gender identity or gender expression), sexual orientation,  parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.</span></span></em></p>

Back to blog

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?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

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...