Site Contracts and Budget Manager
Precision for Medicine · Remote, Serbia
RemotoNão informadoGerente
Publicada há 2 horas
Sobre a vaga
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<p class="x_elementToProof"><span data-olk-copy-source="MessageBody">Precision for Medicine is looking for a <strong>Site Contracts and Budget Manager</strong> to join our European Team. The position can be fully remote from Poland, Slovakia, Serbia, Romania, or Hungary.</span></p>
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<div class="x_elementToProof"><strong>Position Summary:</strong></div>
<div class="x_elementToProof">The primary focus of this role is <strong>global clinical trial budget template development</strong>. You will be responsible for translating complex clinical trial protocols and study documentation into accurate, comprehensive, and negotiation-ready global/site budget templates across multiple countries. <strong>Demonstrated hands-on experience developing investigator/site budget templates for global, sponsor- or CRO-managed clinical trials is required.</strong></div>
<p class="x_elementToProof">The role will <strong>also include</strong> reviewing, drafting, negotiation and tracking of a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements. You will work closely with Clinical Operations study team and play a key role to ensure deliverables are in alignment with defined study timelines.</p>
<div class="x_elementToProof"><strong>Essential functions of the job include but are not limited to:</strong></div>
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<div class="x_elementToProof"><strong>Global Clinical Trial Budget Template Development – Primary Responsibility:</strong></div>
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<div class="x_elementToProof">Review clinical trial protocols, including amendments, SoAs, manuals, and other study documentation to identify all activities with potential site-level cost implications.</div>
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<div class="x_elementToProof">Translate protocol requirements into detailed, accurate, and scalable global/site budget templates.</div>
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<div class="x_elementToProof">Map procedures and activities to applicable study visits and payment milestones.</div>
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<div class="x_elementToProof">Develop per-patient, per-visit, conditional, invoiceable, and one-time study costs.</div>
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<div class="x_elementToProof">Identify costs that may not be apparent from the SoA, including site start-up, pharmacy, laboratory, imaging, record retention/archiving, maintenance, close-out, screen failures, unscheduled visits, participant reimbursement/travel, institutional/overhead, and other pass-through or invoiceable fees.</div>
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<div class="x_elementToProof">Ensure budget structures support appropriate payment terms and CTA exhibits.</div>
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<div class="x_elementToProof">Incorporate approved country-specific cost information and available benchmarks into global and country-level budget templates.</div>
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<div class="x_elementToProof">Establish proposed negotiation targets, parameters, and escalation pathways.</div>
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<div class="x_elementToProof">Perform detailed QC of budget templates before release to assigned SCM negotiators, including verification of formulas, visit totals, conditional procedures, invoiceable items, and patient-cost calculations.</div>
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<div class="x_elementToProof">Confirm consistency between protocol/SoA requirements and completed budgets and clearly document budget assumptions and negotiation parameters.</div>
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<div class="x_elementToProof">Maintain version control and an auditable record of budget-development decisions.</div>
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<div class="x_elementToProof">Review protocol amendments and revised study documents to identify financial impact and update master/site budget templates accordingly.</div>
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<div class="x_elementToProof">Clearly identify added, removed, or modified procedures and associated financial impacts for SCM.</div>
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<div class="x_elementToProof">Serve as a budget-development SME for SCM and study teams and clarify budget assumptions and unusual protocol requirements.</div>
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<div class="x_elementToProof">Support continuous improvement and standardization of global budget templates, tools, SOPs, work instructions, and training.</div>
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<div class="x_elementToProof">Identify opportunities for automation and increased efficiency in clinical trial budget development.</div>
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<div class="x_elementToProof"><strong>Site Contracts – Secondary Responsibility</strong></div>
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<li>Review, draft and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts.</li>
<li>Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues.</li>
<li>Ensure adherence to company policies, procedures and contracting standards.</li>
<li>Update relevant study team members regarding the status of contract negotiations and execution.</li>
<li>Establish, track, report and manage site contract metrics.</li>
<li>Support the maintenance of contract files and databases, including contract archiving.</li>
<li>Assist in designing and implementing policies and procedures to affect the timely execution of contracts.</li>
<li>Recognize where processes can be improved and take corrective action.</li>
<li>Other tasks as assigned.</li>
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<div class="x_elementToProof"><strong>Qualifications:</strong></div>
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<div class="x_elementToProof"><strong>Minimum Required:</strong></div>
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<div class="x_elementToProof">Graduate, postgraduate, or 4-year college degree.</div>
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<div class="x_elementToProof">Experience in a CRO, pharmaceutical, biotechnology, or healthcare environment.</div>
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<div class="x_elementToProof"><strong>At least 5 years of relevant clinical research experience, including substantial hands-on experience developing investigator/site budget templates.</strong></div>
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<div class="x_elementToProof"><strong>Demonstrated experience developing global and/or multi-country clinical trial budget templates for sponsor- or CRO-managed studies is required.</strong></div>
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<div class="x_elementToProof">Strong ability to interpret complex protocols, SoAs, amendments, and supporting study documents and translate requirements into complete site-level costs.</div>
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<div class="x_elementToProof">Experience using country-specific cost information and/or benchmarking data to develop budget assumptions and negotiation parameters.</div>
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<div class="x_elementToProof">Knowledge of CTA budget exhibits, clinical trial payment terms, and site budget negotiation processes.</div>
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<div class="x_elementToProof">Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements, Vendor Contracts and Site Budget negotiations.</div>
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<div class="x_elementToProof">Experience leading interactions with Study Teams and Sponsors.</div>
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<div class="x_elementToProof">Experience with oncology and/or other complex clinical trial protocols.</div>
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<div class="x_elementToProof"><strong>Preferred:</strong></div>
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<div class="x_elementToProof">Bachelors in scientific fields, business administration or equivalent degree</div>
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<li>Excellent organizational and communication skills and attention to detail</li>
<li>Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines.</li>
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<div class="x_elementToProof"><strong>Skills and Competencies:</strong></div>
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<li>Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.</li>
<li>Executes time-sensitive matters while maintaining accuracy and attention to detail.</li>
<li>Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.</li>
<li>Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.</li>
<li>Displays sound business judgment and a proactive, independent work style.</li>
<li>Proficient in MS Office software programs and computer applications</li>
<li>Handles sensitive issues with discretion.</li>
<li>Works well independently and cooperatively with others to achieve common goals in a virtual environment.</li>
<li>Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.</li>
</ul>
<p> </p>
<p>#LI-Remote</p>
<p>#LI-TB1</p>
<p> </p>
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<p> </p><div class="content-conclusion"><hr>
<p>Any data provided as a part of this application will be stored in accordance with our <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&reserved=0">Privacy Policy.</a> For CA applicants, please also refer to our <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&reserved=0">CA Privacy Notice</a>.</p>
<p>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.</p>
<p>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 <a href="mailto:myHR@precisionmedicinegrp.com">myHR@precisionmedicinegrp.com</a>.</p>
<p><span data-teams="true"><strong>Recruitment Fraud Warning: </strong>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 <a id="menur2oq" class="fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn" href="mailto:myHR@precisionmedicinegrp.com" target="_blank">myHR@precisionmedicinegrp.com</a> so we can investigate and take appropriate action.</span></p>
<p><span data-teams="true"><strong><span data-olk-copy-source="MessageBody">Candidates must be legally authorized to work in the country of employment without employer sponsorship.</span></strong></span></p></div>
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