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clinical trial assistant

IQVIA

<div><div>Job Overview
<br>
Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.
<br>
<br>
Essential Functions
<br>
<ul><li>Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
</li><li>Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
</li><li>Assist with periodic review of study files for completeness.
</li><li>Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
</li><li>Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
</li><li>Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
</li><li>May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
</li></ul><br>
Qualifications
<br>
<ul><li>High School Diploma or equivalent Req
</li><li>3 years administrative support experience.
</li><li>Equivalent combination of education, training and experience.
</li><li>Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
</li><li>Written and verbal communication skills including good command of English language.
</li><li>Effective time management and organizational skills.
</li><li>Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
</li><li>Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
</li><li>Knowledge of applicable protocol requirements as provided in company training.
</li></ul></div><p></p><p>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</p></div>

Clinical Trial Assistant

Eli Lilly

<div><p>At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We&rsquo;re looking for people who are determined to make life better for people around the world.</p><p></p><p>
Ensure compliance with local Good Clinical Practice (GCP) Quality System as well as compliance with applicable T&uuml;rkiye MOH regulations.</p><p></p><p><b>
Technical training, personal skills and experience required:</b></p><ul><li><p>
A university degree in Pharmacy from T&uuml;rkiye.</p></li><li><p>
Minimum 2 years&rsquo; experience in quality assurance applied to the pharmaceutical industry.</p></li><li><p>
Working knowledge of GCP regulations and quality system implementation and the ability to interpret and apply them for Quality Assurance (QA) responsibilities</p></li><li><p>
Fluent in English (conversational, writing and reading) Knowledge and mastery of basic computing tools (Microsoft office).</p></li><li><p>
Good interpersonal relations Ability to train working groups.</p></li><li><p>
Good analytical skills and attention to details.</p></li><li><p>
High initiative, learning agility and a flexible, positive attitude.</p></li><li><p>
High degree of accuracy and attentive to details.</p></li></ul><p></p><p><b>
The Responsible Manager Delegate for Clinical Trial Materials is responsible for:</b></p><ul><li><p>
Act as delegated Responsible Manager to Perform Quality checks for the release of the Clinical Trial Products upon arrival to T&uuml;rkiye.</p></li><li><p>
Release clinical trial product shipments that meet all quality specifications and local regulations as a delegated Responsible Manager.</p></li><li><p>
Support inspection readiness activities for MOH inspections. Assure that <b>deviations, change management processes, root cause investigations, and corrective/preventive actions</b> are effectively managed, documented, escalated, and completed in a timely manner.</p></li><li><p>
Monitor compliance with the external party which is responsible for storage and distribution of Clinical Trial Materials.</p></li><li><p>
Assist on training programs to external vendors which might have impact on Clinical Trial Material operations.</p></li><li><p>
Review the returned products, ensure that any potential quality issue or failure that could have originated the return will be reported appropriately and coordinate if new provision applies to these products Support Quality Manager on reviewing/ updating Quality Agreements related to Clinical Trial Products Act as a point of contact for quality release of clinical trial materials in T&uuml;rkiye affiliate.</p></li><li><p>
Provide appropriate escalation of issues clinical teams and affiliate Responsible Manager.</p></li><li><p>
Understand performance metrics related to CT material and identify areas for improvement and simplification.</p></li><li><p>
Understand SOPs and processes for CT materials.</p></li></ul><p></p><p>
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.</p><p></p><p>
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.</p><p></p><p>
#WeAreLilly</p></div>

Junior Responsible Manager Delegate for Clinical Trial Materials

Gilead Sciences

<div><div>At Gilead, we&rsquo;re creating a healthier world for all people. For more than 35 years, we&rsquo;ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer &ndash; working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world&rsquo;s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.</div><div><br>
Every member of Gilead&rsquo;s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we&rsquo;re looking for the next wave of passionate and ambitious people ready to make a direct impact.</div><div><br>
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.<br>
<br>
Job Description</div><div><br>
Regulatory Affairs Manager Turkiye; is responsible from managing RA submissions &amp; supporting Clinical Trials applications and will serve as a core member of the affiliate Regulatory Team interacting with local Regulatory Authorities and other stakeholders to ensure that the company complies with country&rsquo;s applicable legislations.</div><div></div><div>
Knowledge &amp; Details:</div><ul><li><div>
Manage regulatory submissions to local HA submissions inc. but not limited to Pre-MAA related activities (GMP &amp; prioritization applications), marketing Authorisation (MA) applications &amp; variations and other MA maintenance applications, in line with local HA expectations, Gilead SOPs and business objectives for assigned product(s) or projects.</div></li><li><div>
Stay up to date with local and global regulatory requirements (including ICH), internal policies and support the organization in adapting to legislative changes.</div></li><li><div>
Responsible from ensuring the updates to commercial product packaging and labelling in line with product licenses.</div></li><li><div>
Manage clinical trial applications, amendments, and notifications. Collaborate with Clinical Operations and the CT Hub to complete CT submissions to MOH timely and interacts with cross-functional teams internally and externally to ensure submission package fulfils the MoH requirements on time.</div></li><li><div>
Ensure ongoing clinical trials comply with local legislation and oversee investigational product packaging and labelling approvals.</div></li><li><div>
Plan regulatory and clinical timelines and strategies under the guidance of the Regulatory Affairs Director.</div></li><li><div>
Ensure good and strong relationships with functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc.) and with Gilead Sciences Global/Regional RA in order to ensure the success of local and international business results from the regulatory point of view.</div></li><li><div>
Build and maintain networks with regulatory stakeholders, including decision-makers and influencers.</div></li><li><div>
Develop and implement regulatory and clinical trial strategies, and manage negotiations with health authorities.</div></li><li><div>
Actively contribute to local and global initiatives that improve regulatory processes.</div></li></ul><div></div><div>
Professional Experience / Key Skills</div><ul><li><div>
Solid experience in total in Regulatory Affairs &amp; Clinical Trials (if possible) related experience in the Pharmaceutical / Biotech Industry. An advanced degree is desirable.</div></li><li><div>
Degree in Pharmaceutical Sciences or equivalent discipline is preferred.</div></li></ul><ul><li><div>
Proven ability to prioritize, conduct, and manage time to meet project deadlines.</div></li><li><div>
Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.</div></li><li><div>
Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate.</div></li><li><div>
Strong focus on achievement of goals and continuous improvement</div></li><li><div>
Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.</div></li><li><div>
Having excellence in multiple project management, good communication and interpersonal skills.</div></li><li><div>
Be an analytical thinker, problem solver, proactive, initiative taker, creative personality</div></li><li><div>
Team player who actively contributes to the team in order to complete tasks, meet goals or manage projects, actively listen others, respect ideas and aim to improve the process.</div></li><li><div>
Fluency in spoken and written English.</div></li><li><div>
Good decision-making skills are important.</div></li><li><div>
Excellent verbal, written, organization skills and interpersonal communication skills required.</div></li></ul><div></div><div><br>
Equal Employment Opportunity (EEO)</div><div>
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively &quot;Gilead&quot; or the &quot;Company&quot;) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual&rsquo;s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.</div><div></div><div><br>
For Current Gilead Employees and Contractors:</div><div>
Please apply via the Internal Career Opportunities portal in Workday.</div></div>

Regulatory Affairs Manager

Fortrea

<div></div><div><div><p>Fortrea is recruiting an experienced Clinical Project Manager with valuable expertise in Oncology. In this role, you will ensure the successful execution of clinical studies on a local level, while maintaining high-quality standards and regulatory compliance.<i> </i>This position is sponsor-dedicated for a renowned pharmaceutical company.</p><p></p><div><div><div><div><div><div><div><div><div><h3 class="jobSectionHeader"><b><i>
Please note this role is for upcoming future opportunities that may arise at Fortrea.
</i></b></h3></div></div></div></div></div></div></div></div></div></div><p></p><p><b>Summary of Responsibilities:</b></p><ul><li>
Leading the local study teams (consisting of monitors and study administrators) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines</li><li>
Ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived</li><li>
Ensuring timely submissions of proper application/documents to Ethic Committee/Regulatory Authority.</li><li>
Close communication with global study teams and overall responsibility for study commitments, for timely delivery of data to required quality as agreed with global</li><li>
Creating and implementing alternative action plans proactively in order to reach the targeted patient numbers; monitoring the patience admission processes in coordination with the researchers; planning and taking the necessary precaution when required</li><li>
Ensuring the compliance of the clinical research process with ICH-GCP practices, the study protocol, Global and Local Clinical SOP&rsquo;s, and the Ministry of Health Clinical Research Regulations; being knowledgeable about these procedures and keeping abreast of any changes and revision</li><li>
Participating in system/process improvement projects within global and local task groups consisting of employees from different units</li></ul><p></p><p><b>
Qualifications:</b></p><ul><li>
University degree, preferably from Healthcare related areas (Pharmacy, Veterinary, Chemistry, Biology, Medical etc. Faculties),</li><li>
Advanced level of English,</li><li>
Minimum 5 year experiences in Clinical Research (preferably 2 years in Project Management positions and Oncology specific)</li><li>
Project management skills,</li><li>
Strong communication and negotiation skills,</li><li>
Ability to prioritize and handle multiple tasks,</li><li>
Basic coaching skills and good at team work,</li><li>
Financial management skills,</li><li>
Effective planning and organizational skills with result-oriented approach,</li><li>
Stakeholder management experience,</li><li>
Analytical thinking, critical reasoning ability,</li><li>
Good command of MS Office applications,</li><li>
No restriction to travel,</li><li>
Driving License,</li></ul><p></p><p>
Learn more about our EEO &amp; Accommodations request here.</p></div>

Clinical Project Manager sponsor-dedicated

Kiwa Türkiye

<div>
 <strong>
  &Idot;&scedil; &Ouml;zeti
  <br/>
  <br/>
 </strong>
 Kiwa is a world top 20 leader in Testing, Inspection and Certification (TIC). With our certification, inspection, testing, training and consultancy services, we create trust in our customers' products, services, processes, (management) systems and employees. We do so in a wide variety of markets segments, ranging from construction and energy supply to drinking water, healthcare, food, feed &amp; farming. Kiwa employs over 10,000 people in over 40 countries, in Europe, Asia, the Americas and Oceania. Since 2021 we are a member of SHV Family of Companies. We are looking for a &lsquo;CLINICAL SPECIALIST&rsquo; to join our company for our Medical Division, located in Tuzla, &Idot;stanbul.
 <br/>
 <br/>
 <strong>
  &Idot;&scedil; Tan&inodot;m&inodot;
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Checking and reporting compliance of clinical studies and reports in the technical files of the customer communicated to them by Kiwa
  </li>
  <li>
   Current training on clinical evaluation. Tracking the information and documents sent by Kiwa
  </li>
  <li>
   Monitoring and sharing of legal legislation and guide documents related to clinical evaluation published by the EU and Ministry of health
  </li>
  <li>
   Monitoring and sharing of negative events and recall notifications published by the EU, FDA and Ministry of health and sharing with Kiwa
  </li>
  <li>
   Evaluation of new applications submitted by Kiwa and reporting of opinions
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  &Idot;&scedil; Gereklilikleri
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Graduated from Faculty of Medicine or Faculty of Dentistry
  </li>
  <li>
   Work experience in clinical practice with a duration of at least 4 years, related to the use of the medical device or similar products, to the knowledge of the pathology of the condition to be treated and to the relative alternative treatments in relation to the devices and to other products. The person must be currently employed in the field.
  </li>
  <li>
   Knowledge of the current legislation (EU Regulation 2017/745, provisions established by control bodies, etc.) governing medical devices, including the performance and safety requirements set out in Annex I of the MDRMDR which can be demonstrated through relevant work experience or training with a duration of at least 16 hours.
  </li>
  <li>
   Adequate knowledge and experience pertaining to the harmonised standards, of Common Specifications (CS) and relevant guidelines (e.g. ISO 14155, MeddevMeddev 2.7.X, MDCGMDCG, etc.), that regulate the medical devices sector, which can be demonstrated through work experience and training with a duration of at least 16 hours.
  </li>
  <li>
   Knowledge of the relevant KiwaKiwa TR procedures related to clinical data evaluation, demonstrated by specific training conducted by KiwaKiwa TR.
  </li>
  <li>
   Ability to draft records and reports, with the correct performance of the relevant clinical evaluation activities, which can be demonstrated through work experience with a notified body.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Beklentileriniz
  <br/>
  <br/>
 </strong>
 You can constantly improve your personal, professional, and technical competencies by participating in our academy programs that support you and your career.
 <br/>
 <br/>
 Opportunities for global opportunities and rotation among more than ore than 10,000 engaged employees, working from over 40 countries can always knock on your door.
 <br/>
 <br/>
 We always applaud successes with different reward methods.
</div>


Clinical Specialist

DenizBank

<div>
 <p>
  <strong>
   General Qualities
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <ul>
  <li>
   University Graduate,
  </li>
  <li>
   At least 3 years of executive assistant experience,
  </li>
  <li>
   <strong>
    Fluent in English,
   </strong>
  </li>
  <li>
   Strong planning and organizational skills,
  </li>
  <li>
   Strong verbal and written communication skills,
  </li>
  <li>
   Proficient in MS Office programs
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Job Description
  </strong>
 </p>
 <p>
  <strong>
  </strong>
 </p>
 <p>
  To be responsible for the calendar control of the manager, making appointments, meetings and travel organizations, managing telephone and e-mail traffic correctly, quickly and effectively, welcoming and hosting guests.
 </p>
 <p>
  We are looking for a Senior Executive Assistant to be assigned at DenizBank Financial Services Group - Head Office.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <em>
   Ba&scedil;vurunuz nedeni ile payla&scedil;m&inodot;&scedil; oldu&gbreve;unuz veriler 6698 say&inodot;l&inodot; Ki&scedil;isel Verilerin Korunmas&inodot; Kanunu (&ldquo;KVKK&rdquo;) kapsam&inodot;nda korunmakta ve i&scedil;lenmektedir. Ayr&inodot;nt&inodot;l&inodot; bilgi i&ccedil;in
  </em>
  https://basvuru.denizbank.com/KVKK.aspx
  <em>
   adresini ziyaret edebilirsiniz.
  </em>
 </p>
 <p>
 </p>
</div>


Executive Assistant

Anadolu Efes

<div>
 <p>
  <strong>
   Be a part of Anadolu Efes!
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Do you want to be a part of Anadolu Efes? Let&rsquo;s get to know each other!
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  Wherever we are, we strive to add +1 value to the economy, social life, tourism, culture, art, agriculture, sports, and young entrepreneurs by brewing joy.
 </p>
 <p>
  Our journey began on 1969 in the factories we opened in &Idot;zmir. Today, we are one of the top 10 companies in the world in our industry. We have 21 factories, 5 malt and 1 hops processing facility in 6 countries. We are the market leader in Turkey, Russia, Ukraine, Kazakhstan, Georgia and Moldova. You can find us in more than 70 countries in the world!
 </p>
 <p>
  <br/>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   We are hiring an "Executive Assistant &ndash; Market Development Directorate (Fixed-Term)"!
  </strong>
 </p>
 <p>
  We&rsquo;re excited to welcome a new Executive Assistant to our dynamic and multicultural team at Anadolu Efes! This is a unique opportunity to contribute to a global organization that thrives on innovation, diversity, and continuous growth across more than 70 countries.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Who We Are?
  </strong>
 </p>
 <p>
  Our Market Development Directorate is a fast-paced, ambitious, and culturally rich environment. We manage end-to-end business operations in international markets, representing a diverse portfolio of Anadolu Efes and partner brands. We&rsquo;re constantly exploring new opportunities to expand our global footprint and proudly fly the EFES flag around the world.
 </p>
 <p>
  If you&rsquo;re passionate about reaching new heights, energized by complexity, and inspired by cultural diversity, this role is for you.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   What does an Executive Assistant
  </strong>
  <strong>
   do at Anadolu Efes?
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <ul>
  <li>
   Organizing the calendar of the Market Development Director, including meetings, appointments, and travel
  </li>
  <li>
   Managing expat-related processes
  </li>
  <li>
   Assisting team leaders with travel arrangements
  </li>
  <li>
   Handling correspondence, paperwork and document flow smoothly
  </li>
  <li>
   Supporting internal team communications
  </li>
  <li>
   Coordinating and following up on events and team meetings
  </li>
  <li>
   Support the team with office related and administrative needs
  </li>
  <li>
   Collaborating effectively with other departments
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   What are the qualifications we look for in an Executive Assistant
  </strong>
  <strong>
   at Anadolu Efes?
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <ul>
  <li>
   Bachelor&rsquo;s degree in a relevant field
  </li>
  <li>
   Minimum 5 years of experience as an Executive or Department Assistant (preferred)
  </li>
  <li>
   Strong command of MS Office and SAP
  </li>
  <li>
   Advanced proficiency in Excel
  </li>
  <li>
   Excellent written and spoken English
  </li>
  <li>
   Strong planning, organizational, and follow-up skills
  </li>
  <li>
   High self-motivation and a proactive attitude
  </li>
  <li>
   Exceptional communication and representation abilities
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Why Join Us?
  </strong>
 </p>
 <p>
  At Anadolu Efes Market Development Directorate, you&rsquo;ll be part of a team that values different perspectives, learns from one another, and celebrates innovation. You&rsquo;ll work in a volatile yet inspiring environment where your contributions help shape our global success!
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   How do we hire?
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  At Anadolu Efes, we hire without prejudice and discrimination against language, religion, ethnicity, race, gender and sexual orientation. We hire solely based on applicability to the job description measurable examinations, and competency-based interviews.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <em>
    If you find this position to be suitable for you, we are looking forward to your application and for you to add +1 value to our Anadolu Efes family!
   </em>
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <em>
    You can access the Anadolu Efes Employee Candidate Disclosure Statement through the link below:
   </em>
  </strong>
 </p>
 <p>
  https://anadoluefes.com.tr/calisan-adayi-aydinlatma-metni.pdf
 </p>
 <p>
 </p>
</div>


Executive Assistant - Fixed Term

Explore 98+ Clinical trial assistant in Istanbul this December. Find roles across top companies and apply now to boost your career.