regulatory and start up specialist

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lead - planning & operations Jobs in Turkey

lead - planning & operations

production process leader

start up lead

Precision for Medicine

<div><p>Precision for Medicine is hiring an experienced Start Up Lead based in Turkey to join our team.</p>
<p><b>
Position Summary:</b><br>
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.</p><p><br>
<b>
Essential functions of the job include but are not limited to:
</b></p><ul><li>Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.</li><li>Coordinate, develop and present critical path planning including IRB/EC &amp; CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.</li><li>Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.</li><li>Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.</li><li>Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.</li><li>Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.</li><li>Responsible to co-ordinate translations for documents required for submissions.</li><li>Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.</li><li>Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.</li><li>If needed, directly support country or site level activities start up activities.</li><li>Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.</li><li>Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.</li><li>Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.</li><li>Interact with clients in proposal activities, including slide development and client presentation as required.</li><li>Performs other duties as assigned by management.</li></ul><br>
<b>
Qualifications:</b>
<div><b>
Minimum Required:</b><br>
<ul><li>Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.</li><li>Experience in start up from either a CRO or pharmaceutical/biotech industry.</li><li>2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.</li></ul></div>
<div><b>
Other Required:</b><br>
<ul><li>Demonstrated leadership experience in driving cross-functional activities</li><li>Excellent communication and organizational skills are essential.</li><li>Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.</li><li>Fluency in English and for non-English speaking countries the local language of country where position based.</li><li>Experience using milestone tracking tools/systems</li></ul></div><div><br>
<b>
Preferred:</b><br>
<ul><li>Advanced degree in life sciences or related field</li></ul></div>
<div><b>
Competencies:</b><br>
<ul><li>Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.</li><li>Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.</li><li>Excellent organizational skills.</li><li>Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located.</li><li>Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.</li><li>Must demonstrate excellent computer skills.</li><li>Excellent time management and prioritization skills to ensure deadlines are met.</li><li>Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.</li><li>Occasional travel may be required.</li></ul></div><br>
<p></p>
<p>
#LI-NC1 #LI-Remote</p><p></p><div><p><br>
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.</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 QuestionForHR@precisionmedicinegrp.com.</p>
<p>
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.</p></div></div><p></p>

Start up Lead

Precision Medicine Group

<div><p>Precision for Medicine is hiring an experienced Start Up Lead based in Turkey to join our team.</p>
<p><b>
Position Summary:</b><br>
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.</p><p><br>
<b>
Essential functions of the job include but are not limited to:
</b></p><ul><li>Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.</li><li>Coordinate, develop and present critical path planning including IRB/EC &amp; CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.</li><li>Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.</li><li>Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.</li><li>Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.</li><li>Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.</li><li>Responsible to co-ordinate translations for documents required for submissions.</li><li>Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.</li><li>Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.</li><li>If needed, directly support country or site level activities start up activities.</li><li>Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.</li><li>Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.</li><li>Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.</li><li>Interact with clients in proposal activities, including slide development and client presentation as required.</li><li>Performs other duties as assigned by management.</li></ul><br>
<b>
Qualifications:</b>
<div><b>
Minimum Required:</b><br>
<ul><li>Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.</li><li>Experience in start up from either a CRO or pharmaceutical/biotech industry.</li><li>2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.</li></ul></div>
<div><b>
Other Required:</b><br>
<ul><li>Demonstrated leadership experience in driving cross-functional activities</li><li>Excellent communication and organizational skills are essential.</li><li>Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.</li><li>Fluency in English and for non-English speaking countries the local language of country where position based.</li><li>Experience using milestone tracking tools/systems</li></ul></div><div><br>
<b>
Preferred:</b><br>
<ul><li>Advanced degree in life sciences or related field</li></ul></div>
<div><b>
Competencies:</b><br>
<ul><li>Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.</li><li>Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.</li><li>Excellent organizational skills.</li><li>Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located.</li><li>Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.</li><li>Must demonstrate excellent computer skills.</li><li>Excellent time management and prioritization skills to ensure deadlines are met.</li><li>Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.</li><li>Occasional travel may be required.</li></ul></div><br>
<p></p>
<p>
#LI-NC1 #LI-Remote</p><p></p><div><p><br>
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.</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 QuestionForHR@precisionmedicinegrp.com.</p>
<p>
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.</p></div></div>

<div><p>Precision for Medicine is a Clinical Research Organization. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.</p>
<p>
As our company continues we grow we are seeking a Principal Regulatory and Start Up Specialist to join our growing team.</p>
<p>
Essential functions of the job include but are not limited to:</p>
<div>
Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.<br>
<ul><li>Responsible for driving country level submissions and site activation processes by coordinating activities when multiple RSSs are assigned within the country.</li><li>Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.</li><li>Interaction with CA/EC for study purposes and handling responses to the CA/EC.</li><li>Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.</li><li>Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.</li><li>Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.</li><li>Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.</li><li>Prepare, review and manage collection of essential documents required for site activation/IMP release.</li><li>Customize country/site specific Patient Information Sheet and Informed Consent Forms.</li><li>Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.</li><li>Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.</li><li>Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements and other required reviews to secure on time site activation for the assigned sites in the country.</li><li>When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.</li><li>Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within PfM to ensure the conduct of Clinical Trials according to international</li></ul>
and local/national applicable regulations.<br>
<ul><li>Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF</li><li>May support the clinical team performing Pre-Study Site Visits.</li><li>May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.</li><li>Will support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.</li><li>Will support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.</li><li>Will mentor staff on local country regulations, submissions and internal procedures, as well as on PFM SSU specific guidance and tools.</li><li>Can assume ownership of departmental process improvements / initiatives, including finalization, roll out and periodic reviews.</li><li>May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required.</li><li>May act up in the role of Start Up Lead to drive site start up activities to meet activation timelines on smaller or single country studies or by acting as a regional Start Up Lead on larger global studies under the direction of the global Start Up Lead.</li><li>May interact with clients during KOMs, including slide development and client presentation,as required.</li></ul></div><div><br>
Qualifications:<br>
Minimum Required:<br>
<ul><li>Bachelors' degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.</li><li>5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.</li></ul></div><div><br>
Other Required:<br>
<ul><li>Excellent communication and organizational skills are essential.</li><li>Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.</li><li>Fluency in English and Turkish.</li><li>Ability to prioritize workload to meet deadlines.</li><li>Experience in driving cross-functional activities, coordination and oversight of a team.</li></ul></div>
<div>
Preferred:<br>
<ul><li>Must have relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular country. Experience in country set up would be highly beneficial.</li><li>Must have experience using milestone tracking tools/systems.</li><li>Must be able to assist junior SU specialists in problem resolution.</li><li>Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science Competencies</li><li>Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.</li><li>Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.</li><li>Excellent organizational skills.</li><li>Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.</li><li>Must demonstrate excellent computer skills.</li><li>Excellent communication, presentation, interpersonal skills, both written and spoken,</li></ul>
with an ability to inform, influence, convince, and persuade.<br>
<ul><li>Flexible attitude with respect to work assignments and new learning.</li><li>Occasional travel may be required</li></ul></div>
<p>
#LI-OS1 #LI-Remote</p>
<p>
We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.</p><p></p><div><p><br>
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.</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 QuestionForHR@precisionmedicinegrp.com.</p>
<p>
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.</p></div></div><p></p>

Regulatory and Start Up Specialist

<div><p>Precision for Medicine is a Clinical Research Organization. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.</p>
<p>
As our company continues we grow we are seeking a Principal Regulatory and Start Up Specialist to join our growing team.</p>
<p>
Essential functions of the job include but are not limited to:</p>
<div>
Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.<br>
<ul><li>Responsible for driving country level submissions and site activation processes by coordinating activities when multiple RSSs are assigned within the country.</li><li>Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.</li><li>Interaction with CA/EC for study purposes and handling responses to the CA/EC.</li><li>Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.</li><li>Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.</li><li>Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.</li><li>Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.</li><li>Prepare, review and manage collection of essential documents required for site activation/IMP release.</li><li>Customize country/site specific Patient Information Sheet and Informed Consent Forms.</li><li>Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.</li><li>Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.</li><li>Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements and other required reviews to secure on time site activation for the assigned sites in the country.</li><li>When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.</li><li>Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within PfM to ensure the conduct of Clinical Trials according to international</li></ul>
and local/national applicable regulations.<br>
<ul><li>Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF</li><li>May support the clinical team performing Pre-Study Site Visits.</li><li>May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.</li><li>Will support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.</li><li>Will support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.</li><li>Will mentor staff on local country regulations, submissions and internal procedures, as well as on PFM SSU specific guidance and tools.</li><li>Can assume ownership of departmental process improvements / initiatives, including finalization, roll out and periodic reviews.</li><li>May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required.</li><li>May act up in the role of Start Up Lead to drive site start up activities to meet activation timelines on smaller or single country studies or by acting as a regional Start Up Lead on larger global studies under the direction of the global Start Up Lead.</li><li>May interact with clients during KOMs, including slide development and client presentation,as required.</li></ul></div><div><br>
Qualifications:<br>
Minimum Required:<br>
<ul><li>Bachelors' degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.</li><li>5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.</li></ul></div><div><br>
Other Required:<br>
<ul><li>Excellent communication and organizational skills are essential.</li><li>Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.</li><li>Fluency in English and Turkish.</li><li>Ability to prioritize workload to meet deadlines.</li><li>Experience in driving cross-functional activities, coordination and oversight of a team.</li></ul></div>
<div>
Preferred:<br>
<ul><li>Must have relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular country. Experience in country set up would be highly beneficial.</li><li>Must have experience using milestone tracking tools/systems.</li><li>Must be able to assist junior SU specialists in problem resolution.</li><li>Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science Competencies</li><li>Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.</li><li>Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.</li><li>Excellent organizational skills.</li><li>Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.</li><li>Must demonstrate excellent computer skills.</li><li>Excellent communication, presentation, interpersonal skills, both written and spoken,</li></ul>
with an ability to inform, influence, convince, and persuade.<br>
<ul><li>Flexible attitude with respect to work assignments and new learning.</li><li>Occasional travel may be required</li></ul></div>
<p>
#LI-OS1 #LI-Remote</p>
<p>
We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.</p><p></p><div><p><br>
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.</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 QuestionForHR@precisionmedicinegrp.com.</p>
<p>
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.</p></div></div>

BUNQ

<div><p>We believe that a user-centric banking experience should always be underpinned by trust, compliance, and regulatory excellence. That's why as a Transaction Review Lead, your mission is to strengthen our regulatory framework and ensure that our services meet local laws and global standards. Your efforts will play a vital role in safeguarding user trust and helping us deliver on our promise to Make Life Easy for our users</p><p></p><p><b>
Up for this?</b></p><p>
Start your journey by applying today and see if you're the perfect match for us</p><p></p><p><b>
Take ownership:</b></p><p>
As a Transaction Review Lead, you're the cornerstone of ensuring that our processes align with all required laws and regulations while maintaining user trust. You will:</p>
Use data-driven approaches to prioritize, refine, and improve compliance models and processes without compromising efficiency<ul>
Collaborate with key stakeholders (such as first-line teams, risk, and audit) and support the presentation, creation, development, and implementation of AML/CFT and Sanctions regulation requirements <li>️</li>
Ensure internal policies and guidelines are comprehensive, up-to-date, and adapted to comply with evolving local laws and regulations</ul><ul><li>
You have previous experience in AML and KYC and within the financial services sector</li><li>
In-depth understanding of financial regulations, sanctions screening, and compliance auditing across multiple jurisdictions</li><li>
Exceptional communication skills in English, with the ability to translate complex regulations into actionable processes</li><li>
Strong attention to detail with the ability to successfully manage data and compliance processes using a solution-oriented mindset</li><li>
Proven experience leading teams in high-volume operational environments, ensuring efficiency and scalability</li><li>
Hands-on expertise in designing and managing AI-driven workflows that meet AML regulations
</li></ul><p></p><p><i>Curious to see how we make life easy? - try the </i><i>bunq app</i><i>, it only takes 5 minutes to sign up.</i></p><p></p><p><b>
Your space to perform:</b></p><p>
We give you the space and the tools you need to succeed</p><p>
 Great, international colleagues who share your mindset</p><p>
&zwj; Hybrid setup: after 3 months in-office, work 2 days remote, 3 days in-office weekly</p><p>
 We support growth with bunq Academy and &euro;1500 annual learning budget</p><p>
 A massive discount with Urban Sports Club for your wellbeing (in the Netherlands)<br>
&zwj; ️ A Multisport gym card for your health and wellbeing (in Turkey)</p><p>
 Flex Benefits: &euro;70 monthly budget via Re: benefit, offering access to 150+ perks tailored to your lifestyle, including Multisport card, food and fuel vouchers and more</p><p>
 Travel expenses are covered whether you come walking or by bike, bus or car (though we prefer green choices ) (In Turkey and Netherlands)</p><p>
 Digital Nomad Program: After your first year, enjoy up to 20 days per year to work while traveling, combining flexibility with strong team collaboration</p><p>
 We reward tenure with a dedicated travel budget: &euro;1.5k after 2 years and &euro;3k after 4 years to visit another core office.</p><p>
 A MacBook so you can Get Shit Done with us</p><p>
 Delicious lunches from our fabulous in-house chefs with vegan and vegetarian options in the Netherlands and in Turkey and lunch allowance in Bulgaria</p><div>
 An optional pension plan with monthly contribution from bunq (in Netherlands)<br>
<ul><li>️ Private health insurance, just in case (in Turkey or Bulgaria)</li></ul></div><p>
 Monthly contribution to your phone and internet bills (in Turkey and Netherlands)</p><p>
 Friday drinks and other celebrations - bunq style</p><p></p><p><i>
All new hires are subject to Pre-employment Screening (PES), which includes checks conducted by our third-party partner, DISA. This is part of our commitment to a secure and trustworthy workplace</i></p><p><i>
Curious to see how we make life easy? - try the </i><i>bunq app</i><i>, it only takes 5 minutes to sign up.</i></p></div>

Transaction Review Lead

IQVIA

<div>Istanbul, Turkey | Full time | Home-based | R1535388</div>
<br><div><div>To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model. The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.</div><div>
Responsabilities:</div><ul><li>
Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.</li><li>
Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies</li><li>
Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.</li><li>
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.</li><li>
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.</li><li>
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.</li><li>
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.</li><li>
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.</li><li>
Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant Sponsor SOPs and local regulations.</li><li>
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with Sponsor SOPs.</li><li>
Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).</li><li>
Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.</li><li>
Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.</li><li>
Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advices the monitor(s) on study related matters.</li><li>
Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.</li><li>
Proactively identifies risks and facilitates resolution of complex study problems and issues.</li><li>
Organises regular Local Study Team meetings on an agenda driven basis.</li><li>
Actively works towards achieving good personal relationships with all Local Study Team members, sites&rsquo; staff and global stakeholders.</li><li>
Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.</li><li>
Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.</li><li>
Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.</li><li>
Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.</li><li>
Plans and leads National Investigator meet Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.</li><li>
Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.</li><li>
Provides input to process development and improvement.</li><li>
Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.</li><li>
Updates Line Managers about the performance of the CRAs/CSAs.</li><li>
Ensures that study activities at country level comply with local policies and code of ethics.</li><li>
Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.</li><li>
Ensures compliance with Sponsor&acute;s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).</li><li>
Collaborates with local Medical Affairs team.</li><li>
Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.</li></ul><div>
Requirements:</div><ul><li>
Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).</li><li>
Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).</li><li>
Good knowledge of international guidelines ICH GCP as well as relevant local regulations.</li><li>
Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.</li><li>
Good medical knowledge and ability to learn relevant Sponsor Therapeutic Areas</li><li>
Good knowledge of the Drug Development Process.</li><li>
Excellent understanding of the Clinical Study Process including monitoring.</li><li>
Very good understanding of the Study Drug Handling Process and the Data Management Process.</li><li>
Excellent project management skills.</li><li>
Excellent team building and interpersonal skills, organizational skill and verbal and written communication skills</li><li>
Excellent ability to prioritize and handle multiple tasks, attention to details and negotiation skills.</li><li>
Excellent knowledge of spoken and written English and local languages.</li><li>
Good ability to learn and to adapt to work with IT systems.</li><li>
Ability to travel nationally and internationally as required</li></ul><div><i>
&quot;Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered&rdquo;.</i></div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div></div>

Local Study Associate Director - Sponsor Dedicated (m/w/d)

Oredata Yazılım Anonim Şirketi

<div><p>OREDATA is a Digital Transformation &amp; IT Consulting firm with 10+ years of proven expertise and hundreds of successfully implemented projects across the EMEA region. When you join the OREDATA team, you'll be working hand-in-hand with experts focused on tackling digital, operational, analytical &amp; data science challenges with the greatest impact. We foster collaboration with proximity, an agile and autonomous approach and best practices and guiding principles.</p><p>
Read more: https://medium.com/@oredata-engineering</p><p>
Apply and be part of our exciting journey!</p><p></p><p><b>
Requirements</b></p><ul><li>
Bachelor&rsquo;s or Master&rsquo;s degree in Computer Science, Data Science, Statistics, Engineering, or a related field
</li><li>8+ years of professional experience in data science, machine learning, or analytics roles
</li><li>Experience working on AI / Machine Learning projects (model development, data-driven solutions, analytics use cases)
</li><li>Experience leading or coordinating data science teams (team coordination, task prioritization, delivery management)
</li><li>Experience in stakeholder management (business&ndash;technical communication, requirement alignment)
</li><li>Ability to translate business problems into data-driven solutions (problem framing, analytical thinking, solution design)
</li><li>Hands-on experience in data analysis and validation (data exploration, hypothesis testing, insight generation)
</li><li>Experience working as a bridge between business units and technical teams (cross-functional collaboration, communication)
</li><li>Experience using Jira for task tracking, backlog management, and team coordination is a plus
</li><li>Experience managing end-to-end problem-solving processes (problem definition, solution approach, execution coordination)
</li><li>Ability to lead and facilitate meetings, workshops, and decision-making sessions (technical and business alignment)
</li><li>Strong communication skills with a data-driven and result-oriented mindset</li></ul><p></p><p><b>
Get to know us</b></p><p>
If you want to know more about us and what we do, then visit our website: www.oredata.com</p><p><b>
Why Oredata?</b></p><ul><li>
Remote working and flexible time off</li><li>
Open communication, flexibility and start-up spirit</li><li>
Learning &amp; Development opportunities for both personal and professional growth</li><li>
Opportunity to get company paid Professional Certificates (Google Cloud Platform, Confluent Kafka, etc)</li><li>
Access to Online Training Platforms (Udemy, Pluralsight, A Cloud Guru, Coursera, etc.)</li><li>
Dynamic work ecosystem where you can take initiative and responsibility</li><li>
Opportunity to work on international projects</li><li>
Private Health Insurance</li><li>
Birthday Leave Policy</li></ul><p></p><p><b>
Kişisel verileriniz işe alım s&uuml;recinin y&uuml;r&uuml;t&uuml;lebilmesi amacıyla veri sorumlusu sıfatıyla şirketimiz Oredata Yazılım A.Ş. tarafından işlenecektir.</b> Kişisel verilerinizin işlenmesi ve haklarınızla ilgili detaylı bilgiye https://oredata.com/personal-data-protection-policy/ bağlantısı &uuml;zerinden ulaşabilirsiniz.</p></div>

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