Director, Site Start up

<div class="x_elementToProof">Precision for Medicine is hiring a Director, Site Start up to join our team.  We can consider candidates working remotely in the UK, Spain, Poland, Hungary, Serbia, Slovakia or Romania.</div> <div class="x_elementToProof"> </div> <div class="x_elementToProof"><strong>Position Summary:</strong></div> <div class="x_elementToProof">Provides leadership to the Site Start-up (SSU) department. Contributes to the strategy and direction of the implementation and expansion of the SSU department in terms of people, processes and systems. Collaborates with other functions to secure SSU delivery and client satisfaction on SSU activities (typically, these include activities such as Informed Consent Form review and adaptation, Regulatory Document collection and quality review, Support to Regulatory and sites on IRB/EC/CA submissions and support to Site Contracts group in budget and contract negotiation). Works closely with<span class="x_spanWithBackgroundColor"> the Head of Site Start Up </span>on the ongoing development of SSU . Ensures the conduct and delivery of clinical trials in compliance with Regulatory requirements (local and regional), ICH Guidelines, Good Clinical Practices (ICH) and SOPs.</div> <div class="x_elementToProof"> </div> <div class="x_elementToProof"><strong>Essential functions of the job include but are not limited to: </strong></div> <ul> <li> <div class="x_elementToProof">Provides SSU team  with guidance, leadership and overall support relating to SSU project delivery, communication, human resources, revenue enhancement, procedures, systems and processes to meet client and departmental targets.</div> </li> <li> <div class="x_elementToProof">Supports the overall management of site start up delivery either by direct management and/or cross functional oversight of the depts involved in the different areas of site start-up (Local/Central IRB/Ethics Committee (EC) submissions, Competent Authorities (CA) submissions, other related governing organizations/bodies, site contracts and budget negotiations and any other start up requirements). </div> </li> <li> <div class="x_elementToProof">Works closely with the<span class="x_spanWithBackgroundColor"> Head of Site Start Up </span>to establish the Precision for Medicine (PFM) SSU framework to ensure project execution and delivery including SSU intelligence, tools and methodology, risk evaluations and mitigations. </div> </li> <li> <div class="x_elementToProof">Supports SSU collaboration with Clinical Operations team, project management and other relevant cross functional departments in the planning, execution and governance of SSU activities globally and/or regionally </div> </li> <li> <div class="x_elementToProof">Works with<span class="x_spanWithBackgroundColor"> the Head of Site Start Up </span>to support defined corporate and departmental business strategies for PfM </div> </li> <li> <div class="x_elementToProof">Acts as an ambassador for change management for evolution of global structure for PFM growth and expansion </div> </li> <li> <div class="x_elementToProof">Provide leadership and oversight on SSU programs including large programs or programs that are increasingly complex (in scope, revenue contribution, volume and design) </div> </li> <li> <div class="x_elementToProof">Manage escalations and remediation of SSU concerns timely and effectively </div> </li> <li> <div class="x_elementToProof">Supports optimization of processes and delivery with the goal of contributing to the profitability of the SSU teams to meet or exceed budget targets </div> </li> <li> <div class="x_elementToProof">Partner with Global Resourcing teams for assessment and management of team members (SSU leads, SSU Specialist and Site Contract Management staff) to ensure that established cost, time, and quality goals are met </div> </li> <li> <div class="x_elementToProof">Supports SSU team career development, growth and succession planning activities. Ensures compliance with company policies and procedures and other applicable regulatory guidelines </div> </li> <li> <div class="x_elementToProof">Supports coordination of SSU Lead’s participation in current and prospective client meetings and presentations to ensure PfM customer service is well represented </div> </li> <li> <div class="x_elementToProof">Collaborates with Business Development in opportunity development, proposals and budgeting, bid defense preparation and attendance for any SSU participants </div> </li> <li> <div class="x_elementToProof">Works with global/regional functional leaders to support SSU project strategy and SSU delivery </div> </li> <li> <div class="x_elementToProof">Supports SSU evaluations and implements required changes for all projects </div> </li> <li> <div class="x_elementToProof">Develop, measure and report SSU KPIs and lead continuous improvement </div> </li> <li> <div class="x_elementToProof">Recognize, exemplify, and adhere to PFM’s values that center on our commitment to quality, our people, clients and performance </div> </li> <li> <div class="x_elementToProof">Leverage communication skills and experience to reinforce PfM culture and values to motivate, maintain engagement and drive retention for SSU team</div> </li> </ul> <div class="x_elementToProof"><strong>Job Qualifications:</strong></div> <ul> <li> <div class="x_elementToProof">Bachelors degree in life sciences or related field or equivalent combination of education, training, and experience.</div> </li> <li> <div class="x_elementToProof">A minimum of 12 years in clinical research including extensive experience of Site Start-up </div> </li> <li>Experience working for a Clinical Research Organisation (CRO)</li> <li>Experience in people management </li> <li> <div class="x_elementToProof">Expert knowledge of GCP/ICH guidelines and the clinical development process.</div> </li> <li> <div class="x_elementToProof">Demonstrated leadership track record </div> </li> <li> <div class="x_elementToProof">Experience working in team environment with resource management experience </div> </li> <li> <div class="x_elementToProof">Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) and clinical software experience (CTMS, eTMF, EDC etc) </div> </li> <li> <div class="x_elementToProof">Excellent communication and interpersonal skills to effectively interface with others in a team setting </div> </li> <li> <div class="x_elementToProof">Excellent organizational skills, attention to detail, and a customer service demeanor </div> </li> <li> <div class="x_elementToProof">Proven experience in strategic planning, risk management and change management </div> </li> <li> <div class="x_elementToProof">Fluency in English.</div> </li> </ul> <div class="x_elementToProof"> <div class="x_elementToProof">Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease.</div> <div class="x_elementToProof"> </div> <div class="x_elementToProof">#LI-NC1 #LI-Remote</div> </div> <p> </p> <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></div>