<p><span><strong>TFS</strong></span><strong> </strong><span><strong>HealthScience</strong></span> is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service Provider (FSP) <span>solutions.</span></p><p><span><strong>Join</strong></span><strong> </strong><span><strong>Our</strong></span><strong> </strong><span><strong>Team</strong></span><strong> </strong><span><strong>as</strong></span><strong> </strong><span><strong>a</strong></span><strong> </strong><span><strong>Clinical</strong></span><strong> </strong><span><strong>Research</strong></span><strong> </strong><span><strong>Manager</strong></span><strong> </strong><span><strong>(CRM) - home based in Poland, Spain or Italy. </strong></span></p><div><p><span>At</span> <span>TFS</span> <span>HealthScience,</span> <span>you</span> <span>will</span> <span>be</span> <span>part</span> <span>of</span> <span>a</span> <span>global</span> <span>team</span> <span>dedicated</span> <span>to</span> <span>advancing</span> <span>innovative</span> <span>therapies</span> <span>and</span> <span>improving</span> <span>patient</span> <span>outcomes.</span> <span>We</span> <span>are</span> <span>looking</span> <span>for</span> <span>an</span> <span>experienced</span> <span><strong>Clinical</strong></span><strong> </strong><span><strong>Research</strong></span><strong> </strong><span><strong>Manager</strong></span><strong> </strong><span><strong>(CRM)</strong></span> <span>to</span> <span>join</span> <span>our</span> <span><strong>Ophthalmology</strong></span> <span>team</span> <span>and</span> <span>play</span> <span>a</span> <span>key</span> <span>role</span> <span>in</span> <span>overseeing</span> <span>clinical</span> <span>trial</span> <span>operations</span> <span>across</span> <span>multiple</span> <span>studies</span> <span>and</span> <span>countries.</span></p></div><div><p><span>This</span> <span>is</span> <span>a</span> <span>full-time,</span> <span>home-based</span> <span>opportunity</span> <span>open</span> <span>to</span> <span>candidates</span> <span>located</span> <span>in</span> <span><strong>Poland,</strong></span><strong> </strong><span><strong>Spain,</strong></span><strong> </strong><span><strong>or</strong></span><strong> </strong><span><strong>Italy</strong></span></p><p></p></div><p><span><strong>About</strong></span><strong> </strong><span><strong>this</strong></span><strong> </strong><span><strong>role</strong></span></p><div><p><span>As</span> <span>part</span> <span>of</span> <span>our</span> <span><strong>Ophthalmology</strong></span> <span>team,</span> <span>you</span> <span>will</span> <span>work</span> <span>alongside</span> <span>passionate</span> <span>and</span> <span>innovative</span> <span>professionals</span> <span>to</span> <span>ensure</span> <span>our</span> <span>customers</span> <span>achieve</span> <span>their</span> <span>clinical</span> <span>development</span> <span>goals.</span><br></p></div><div><p><span>The</span> <span><strong>Clinical</strong></span><strong> </strong><span><strong>Research</strong></span><strong> </strong><span><strong>Manager</strong></span><strong> </strong><span><strong>(CRM)</strong></span> <span>will</span> <span>be</span> <span>responsible</span> <span>for</span> <span>coordinating</span> <span>and</span> <span>overseeing</span> <span>country</span> <span>and</span> <span>site</span> <span>management</span> <span>activities</span> <span>during</span> <span>study</span> <span>conduct</span> <span>in</span> <span>compliance</span> <span>with</span> <span>company</span> <span>policies,</span> <span>SOPs,</span> <span>ICH-GCP</span> <span>guidelines,</span> <span>regulatory</span> <span>requirements,</span> <span>and</span> <span>contractual</span> <span>obligations.</span></p></div><div><p><span>You</span> <span>will</span> <span>work</span> <span>closely</span> <span>with</span> <span>Project</span> <span>Managers,</span> <span>Clinical</span> <span>Research</span> <span>Associates</span> <span>(CRAs),</span> <span>sponsors,</span> <span>and</span> <span>investigative</span> <span>sites</span> <span>to</span> <span>ensure</span> <span>studies</span> <span>are</span> <span>delivered</span> <span>on</span> <span>time,</span> <span>within</span> <span>scope,</span> <span>and</span> <span>to</span> <span>the</span> <span>highest</span> <span>quality</span> <span>standards.</span></p><p></p></div><p><span><strong>Key</strong></span><strong> </strong><span><strong>Responsibilities</strong></span></p><ul><li><p><span>Manage</span> <span>day-to-day</span> <span>clinical</span> <span>operations</span> <span>activities</span> <span>for</span> <span>assigned</span> <span>projects</span> <span>in</span> <span>accordance</span> <span>with</span> <span>study</span> <span>protocols,</span> <span>contracts,</span> <span>SOPs,</span> <span>ICH-GCP</span> <span>guidelines,</span> <span>and</span> <span>applicable</span> <span>regulations.</span></p></li><li><p><span>Serve</span> <span>as</span> <span>the</span> <span>primary</span> <span>sponsor</span> <span>contact</span> <span>for</span> <span>operational</span> <span>project-specific</span> <span>issues</span> <span>and</span> <span>study</span> <span>deliverables.</span></p></li><li><p><span>Lead,</span> <span>coach,</span> <span>and</span> <span>support</span> <span>CRAs,</span> <span>ensuring</span> <span>project-specific</span> <span>training</span> <span>requirements</span> <span>are</span> <span>completed</span> <span>and</span> <span>documented.</span></p></li><li><p><span>Oversee</span> <span>site</span> <span>quality</span> <span>and</span> <span>monitoring</span> <span>deliverables</span> <span>through</span> <span>direct</span> <span>supervision</span> <span>and</span> <span>guidance</span> <span>of</span> <span>study</span> <span>teams.</span></p></li><li><p><span>Develop</span> <span>and</span> <span>implement</span> <span>study</span> <span>monitoring</span> <span>plans,</span> <span>site</span> <span>training</span> <span>plans,</span> <span>and</span> <span>verification</span> <span>initiatives.</span></p></li><li><p><span>Coordinate</span> <span>investigator</span> <span>meetings</span> <span>and</span> <span>support</span> <span>site</span> <span>and</span> <span>country-level</span> <span>study</span> <span>reporting</span> <span>activities.</span></p></li><li><p><span>Ensure</span> <span>study</span> <span>processes</span> <span>and</span> <span>operational</span> <span>strategies</span> <span>remain</span> <span>practical</span> <span>and</span> <span>effective</span> <span>from</span> <span>feasibility</span> <span>through</span> <span>study</span> <span>closeout.</span></p></li><li><p><span>Act</span> <span>as</span> <span>the</span> <span>primary</span> <span>point</span> <span>of</span> <span>contact</span> <span>for</span> <span>CRAs</span> <span>and</span> <span>monitoring</span> <span>teams,</span> <span>providing</span> <span>guidance</span> <span>on</span> <span>site-related</span> <span>challenges</span> <span>and</span> <span>escalations.</span></p></li><li><p><span>Support</span> <span>recruitment</span> <span>and</span> <span>monitoring</span> <span>strategies</span> <span>to</span> <span>optimize</span> <span>study</span> <span>performance.</span></p></li><li><p><span>Conduct</span> <span>co-monitoring</span> <span>visits</span> <span>to</span> <span>ensure</span> <span>quality</span> <span>oversight</span> <span>and</span> <span>consistency</span> <span>across</span> <span>monitoring</span> <span>activities.</span></p></li><li><p><span>Review</span> <span>and</span> <span>approve</span> <span>monitoring</span> <span>visit</span> <span>reports,</span> <span>ensuring</span> <span>timely</span> <span>resolution</span> <span>and</span> <span>escalation</span> <span>of</span> <span>identified</span> <span>issues.</span></p></li><li><p><span>Review</span> <span>monitoring</span> <span>schedules</span> <span>and</span> <span>site</span> <span>visit</span> <span>calendars</span> <span>to</span> <span>ensure</span> <span>compliance</span> <span>with</span> <span>monitoring</span> <span>plans.</span></p></li><li><p><span>Monitor</span> <span>protocol</span> <span>deviations,</span> <span>data</span> <span>listings,</span> <span>and</span> <span>quality</span> <span>metrics</span> <span>to</span> <span>proactively</span> <span>identify</span> <span>risks</span> <span>and</span> <span>implement</span> <span>mitigation</span> <span>strategies.</span></p></li><li><p><span>Lead</span> <span>study</span> <span>team</span> <span>meetings</span> <span>and</span> <span>provide</span> <span>regular</span> <span>updates</span> <span>to</span> <span>Project</span> <span>Managers</span> <span>regarding</span> <span>site</span> <span>and</span> <span>country</span> <span>performance.</span></p></li><li><p><span>Ensure</span> <span>accurate</span> <span>maintenance</span> <span>of</span> <span>study</span> <span>documentation</span> <span>and</span> <span>Trial</span> <span>Master</span> <span>File</span> <span>(TMF)</span> <span>quality,</span> <span>when</span> <span>delegated.</span></p></li><li><p><span>Review</span> <span>CTMS</span> <span>data</span> <span>to</span> <span>ensure</span> <span>timely</span> <span>and</span> <span>accurate</span> <span>recording</span> <span>of</span> <span>country,</span> <span>site,</span> <span>and</span> <span>subject</span> <span>information.</span></p></li><li><p><span>Support</span> <span>investigator</span> <span>payment</span> <span>tracking</span> <span>and</span> <span>approval</span> <span>processes</span> <span>when</span> <span>delegated.</span></p></li><li><p><span>Collaborate</span> <span>with</span> <span>Project</span> <span>Managers</span> <span>on</span> <span>CRA</span> <span>onboarding,</span> <span>training,</span> <span>and</span> <span>handover</span> <span>activities.</span></p></li><li><p><span>Contribute</span> <span>to</span> <span>study</span> <span>communications,</span> <span>newsletters,</span> <span>and</span> <span>operational</span> <span>updates.</span></p></li><li><p><span>Provide</span> <span>project</span> <span>insights</span> <span>related</span> <span>to</span> <span>resource</span> <span>utilization,</span> <span>revenue</span> <span>recognition,</span> <span>and</span> <span>forecasting</span> <span>activities.</span></p></li><li><p><span>Participate</span> <span>in</span> <span>Investigator</span> <span>Meetings</span> <span>and</span> <span>present</span> <span>monitoring</span> <span>requirements</span> <span>and</span> <span>expectations</span> <span>when</span> <span>required.</span></p></li><li><p><span>Promote</span> <span>proactive</span> <span>issue</span> <span>resolution</span> <span>and</span> <span>a</span> <span>solution-oriented</span> <span>approach</span> <span>across</span> <span>study</span> <span>teams.</span></p></li><li><p><span>Partner</span> <span>with</span> <span>CRA</span> <span>Line</span> <span>Managers</span> <span>regarding</span> <span>study</span> <span>assignments,</span> <span>workload</span> <span>planning,</span> <span>and</span> <span>performance</span> <span>discussions.</span></p></li><li><p><span>Support</span> <span>business</span> <span>development</span> <span>initiatives,</span> <span>proposals,</span> <span>budget</span> <span>development,</span> <span>and</span> <span>bid</span> <span>defense</span> <span>activities</span> <span>as</span> <span>required.</span></p></li></ul><p><span><strong>Qualifications</strong></span></p><ul><li><p><span>Bachelor's</span> <span>degree</span> <span>in</span> <span>Life</span> <span>Sciences,</span> <span>Clinical</span> <span>Research,</span> <span>Nursing,</span> <span>Pharmacy,</span> <span>or</span> <span>another</span> <span>health-related</span> <span>field.</span></p></li><li><p><span>Minimum</span> <span>of</span> <span>5</span> <span>years</span> <span>of</span> <span>clinical</span> <span>research</span> <span>experience,</span> <span>including</span> <span>significant</span> <span>experience</span> <span>as</span> <span>a</span> <span>Clinical</span> <span>Research</span> <span>Associate</span> <span>(CRA)</span> <span>with</span> <span>independent</span> <span>on-site</span> <span>monitoring</span> <span>responsibilities.</span></p></li><li><p><span><strong>Minimum 1 year experience as an Unmasked CRA / CRM in an Ophthalmology study</strong>.</span></p></li><li><p><span>Experience</span> <span>coordinating</span> <span>or</span> <span>overseeing</span> <span>clinical</span> <span>trial</span> <span>operations</span> <span>at</span> <span>a</span> <span>study,</span> <span>country,</span> <span>or</span> <span>regional</span> <span>level.</span></p></li><li><p><span>Strong</span> <span>understanding</span> <span>of</span> <span>clinical</span> <span>trial</span> <span>processes</span> <span>from</span> <span>start-up</span> <span>through</span> <span>closeout.</span></p></li><li><p><span>In-depth</span> <span>knowledge</span> <span>of</span> <span>Good</span> <span>Clinical</span> <span>Practice</span> <span>(ICH-GCP),</span> <span>regulatory</span> <span>requirements,</span> <span>and</span> <span>clinical</span> <span>research</span> <span>standards.</span><br><br><strong>For candidates based in </strong><span><strong><em>Italy</em></strong></span></p><p><span>Salary: โฌ63,000 โ โฌ65,000 gross/year, in line with CCNL Terziario-Servizi (Level III), plus benefits (lunch vouchers, health insurance, pension, and car allowance where applicable).</span><br></p><p><span><em> We welcome applications from candidates belonging to protected categories under art. 1 L. 68/99.</em></span></p></li></ul><p><span><strong>What</strong></span><strong> </strong><span><strong>We</strong></span><strong> </strong><span><strong>Offer</strong></span></p><div><p><span>We</span> <span>provide</span> <span>a</span> <span>competitive</span> <span>compensation</span> <span>package,</span> <span>comprehensive</span> <span>benefits,</span> <span>and</span> <span>the</span> <span>opportunity</span> <span>for</span> <span>personal</span> <span>and</span> <span>professional</span> <span>growth</span> <span>in</span> <span>a</span> <span>rewarding</span> <span>environment.</span> <span>You'll</span> <span>be</span> <span>joining</span> <span>a</span> <span>team</span> <span>that</span> <span>values</span> <span>collaboration,</span> <span>innovation,</span> <span>and</span> <span>making</span> <span>a</span> <span>difference</span> <span>in</span> <span>the</span> <span>lives</span> <span>of</span> <span>patients.</span></p></div><div><p><span>At</span> <span>TFS</span> <span>HealthScience,</span> <span>you'll</span> <span>have</span> <span>the</span> <span>opportunity</span> <span>to</span> <span>work</span> <span>on</span> <span>diverse</span> <span>and</span> <span>impactful</span> <span>clinical</span> <span>development</span> <span>programs</span> <span>while</span> <span>collaborating</span> <span>with</span> <span>talented</span> <span>colleagues</span> <span>across</span> <span>the</span> <span>globe.</span></p><p></p></div><p><span><strong>A</strong></span><strong> </strong><span><strong>Bit</strong></span><strong> </strong><span><strong>More</strong></span><strong> </strong><span><strong>About</strong></span><strong> </strong><span><strong>Us</strong></span></p><p><span>Our</span> <span>journey</span> <span>began</span> <span>over</span> <span>25</span> <span>years</span> <span>ago</span> <span>in</span> <span>Sweden,</span> <span>in</span> <span>the</span> <span>city</span> <span>of</span> <span>Lund.</span> <span>As</span> <span>a</span> <span>global</span> <span>CRO</span> <span>with</span> <span>the</span> <span>ultimate</span> <span>goal</span> <span>of</span> <span>ensuring</span> <span>patients'</span> <span>safety</span> <span>and</span> <span>well-being,</span> <span>we</span> <span>provide</span> <span>biotechnology</span> <span>and</span> <span>pharmaceutical</span> <span>companies</span> <span>with</span> <span>tailored</span> <span>clinical</span> <span>development</span> <span>solutions.</span> <span>We</span> <span>currently</span> <span>operate</span> <span>in</span> <span>17</span> <span>countries</span> <span>across</span> <span>Europe,</span> <span>North</span> <span>America,</span> <span>Asia</span> <span>Pacific,</span> <span>and</span> <span>the</span> <span>Middle</span> <span>East.</span></p><div><p><span>Our</span> <span>core</span> <span>values</span> <span>of</span> <span><strong>Trust,</strong></span><strong> </strong><span><strong>Quality,</strong></span><strong> </strong><span><strong>Flexibility,</strong></span><strong> </strong><span><strong>and</strong></span><strong> </strong><span><strong>Passion</strong></span> <span>are</span> <span>what</span> <span>make</span> <span>TFS</span> <span>HealthScience</span> <span>the</span> <span>successful</span> <span>company</span> <span>it</span> <span>is</span> <span>today.</span> <span>These</span> <span>values</span> <span>shape</span> <span>our</span> <span>culture,</span> <span>reflect</span> <span>what</span> <span>we</span> <span>stand</span> <span>for,</span> <span>and</span> <span>guide</span> <span>how</span> <span>we</span> <span>work</span> <span>every</span> <span>day.</span><br></p></div><div><p><span><strong>#TogetherWeMakeADifference</strong></span></p></div>
How to apply
This role is published on Tfscro's own careers page and is listed here so European professionals can find it. Applications are handled by the employer directly, with no third party in between.
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