Qureos Mentor

Parexel

<div></div><div><div><div><div><p><b>Key Accountabilities</b><b>:</b></p></div><p></p><div><p><b>
Site Management Responsibilities</b></p></div><div><ul><li><p>
Contributes to the selection of potential investigators.</p></li></ul></div><div><ul><li><p>
In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.</p></li></ul></div><div><ul><li><p>
Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.</p></li></ul></div><div><ul><li><p>
Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready.</p></li></ul></div><div><ul><li><p>
Actively participates in Local Study Team (LST) meetings.</p></li></ul></div><div><ul><li><p>
Contributes to National Investigators meetings, as applicable.</p></li></ul></div><div><ul><li><p>
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.</p></li></ul></div><div><ul><li><p>
Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.</p></li></ul></div><div><ul><li><p>
Updates CTMS and other systems with data from study sites as per required timelines.</p></li></ul></div><div><ul><li><p>
Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.</p></li></ul></div></div><div><div><ul><li><p>
Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.</p></li></ul></div><div><ul><li><p>
Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.</p></li></ul></div><div><ul><li><p>
Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.</p></li></ul></div><div><ul><li><p>
Ensures data query resolution in a timely manner.</p></li></ul></div><div><ul><li><p>
Works with data management to ensure robust quality of the collected study data.</p></li></ul></div><div><ul><li><p>
Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.</p></li></ul></div><div><ul><li><p>
Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.</p></li></ul></div><div><ul><li><p>
Follows up on outstanding actions with study sites to ensure resolution in a timely manner.</p></li></ul></div><div><ul><li><p>
Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.</p></li></ul></div><div><ul><li><p>
Assists site in maintaining inspection ready ISF.</p></li></ul></div><div><ul><li><p>
Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).</p></li></ul></div><div><ul><li><p>
Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.</p></li></ul></div><div><ul><li><p>
 Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.</p></li></ul></div><div><ul><li><p>
Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.</p></li></ul></div><div><ul><li><p>
Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager</p></li></ul></div><p></p><div><p><b>
Compliance with Sponsor Standards</b></p></div><div><ul><li><p>
Ensures compliance with the Client&rsquo;s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).</p></li></ul></div><div><ul><li><p>
Ensures compliance with local, national, and regional legislation, as applicable.</p></li></ul></div><div><ul><li><p>
Completes timesheets accurately as required</p></li></ul></div></div><p></p><div><div><p><b>
Compliance with Parexel Standards</b></p></div><div><ul><li><p>
Complies with required training curriculum.</p></li></ul></div><div><ul><li><p>
Completes timesheets accurately as required.</p></li></ul></div><div><ul><li><p>
Submits expense reports as required.</p></li></ul></div><div><ul><li><p>
Updates CV as required.</p></li></ul></div><div><ul><li><p>
Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.</p></li></ul></div><div><p><b>
Skills (Essential):</b></p></div><div><ul><li><p>
Excellent attention to detail.</p></li></ul></div><div><ul><li><p>
Good written and verbal communication skills.</p></li></ul></div><div><ul><li><p>
Good collaboration and interpersonal skills.</p></li></ul></div><div><ul><li><p>
Good negotiation skills.</p></li></ul></div><div><ul><li><p>
Proficient in written and spoken English language required.</p></li></ul></div><div><ul><li><p>
Fluency in local language(s) required.</p></li></ul></div><div><p><b>
Skills (Desirable):</b></p></div><div><ul><li><p>
Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.</p></li></ul></div><div><ul><li><p>
Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.</p></li></ul></div><div><ul><li><p>
Good analytical and problem-solving skills.</p></li></ul></div><div><ul><li><p>
Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.</p></li></ul></div><div><ul><li><p>
Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.</p></li></ul></div></div><div><div><ul><li><p>
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential):</p></li></ul></div><div><ul><li><p>
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. &bull; Good knowledge of relevant local regulations.</p></li></ul></div><div><ul><li><p>
Good medical knowledge and ability to learn relevant Client Therapeutic Areas.</p></li></ul></div><div><ul><li><p>
Basic understanding of the drug development process.</p></li></ul></div><div><ul><li><p>
Good understanding of Clinical Study Management including monitoring, study drug handling and data management.</p></li></ul></div><p></p><div><p><b>
Knowledge and Experience (Desirable):</b></p></div><div><ul><li><p>
Familiar with risk-based monitoring approach including remote monitoring.</p></li></ul></div><div><ul><li><p>
Good cultural awareness.</p></li></ul></div><p></p><div><p><b>
Education</b><b>:</b></p></div><div><ul><li><p>
Bachelor&rsquo;s degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.</p></li></ul></div><div><p><b>
Other</b><b>:</b></p></div><div><ul><li><p>
Ability to travel nationally/internationally as required.</p></li></ul></div><div><ul><li><p>
Valid driving license per country requirements, as applicable</p></li></ul></div></div><br>
<p></p>
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Senior Clinical Research Associate

<div></div><div><div><ul><li>Around 7-10 years of relevant experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets.</li><li>
Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.</li><li>
Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.</li><li>
Responsible for managing (Authoring and Review) of biosimilar investigational product submission such as IND &amp; IMPD for USFDA, EMA</li><li>
Authoring, review, and submission of BLA/MAA of biosimilar dossiers for US/EU/ROW /India markets.</li><li>
Preparation / Review of Regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, BLA, NDA, and MAA applications.</li><li>
Life cycle management (LCM) for approved products. (Annual reports, variations, renewals) for Europe (Type IA/IB/II/IAIN) / US and other ROW markets.</li><li>
Evaluation of change controls and deviations and defining regulatory strategy .</li><li>
Co-ordination with internal and external stake holders for documentation required for filing. Identify quality and/or timeliness issues with source documents, as early as possible</li><li>
Develop up-to-date knowledge about regulatory guideline updates and applies regulatory requirements and their impact on submissions.</li><li>
Working experience in Regulatory Information Management Systems like Veeva Vault.</li><li>
Strong communications skills and ability to guide and mentor team members.</li><li>
Ability to work independently.</li><li>
Review and submit safety variations to Health Authorities and perform post Approval CMC / labeling related updates.</li><li>
Authoring content of the label (EU, Canada, AU/NZ &amp; US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.</li><li>
Familiarity with EU Guidelines for QRD / Excipients.</li><li>
Artwork management for countries with label in English.</li></ul><p></p>
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Regulatory Affairs Consultant (Biologics/Small Molecules)

<p></p><div><b>Primary Location:</b> Turkey, Remote
<div><b>Job ID</b> R0000035701</div>
<p><b>Category</b> Clinical Trials</p>
<div></div><div>
</div><div></div><div><h2 class="jobSectionHeader"><b>ABOUT THIS ROLE</b></h2>
</div><div><p>Parexel FSP is hiring Local Study Associate Directors to join us on a</p><p>
permanent full-time, home-based basis.</p><p>
The role requires working in a hybrid model, with 3 days/week at the sponsors office (Istanbul, Ankara, or Izmir).</p><p>
If you&rsquo;re driven by the potential of science to create meaningful change and</p><p>
eager to explore your capabilities, join us.</p><p>
Dedicated to a single sponsor in BioPharma, who is revolutionizing healthcare by harnessing the power of science to benefit people, society, and the planet. Turkey is a vital part of their global network, hosting colleagues from every segment of the life sciences value chain. Their science-driven approach aims to transform healthcare and improve patient outcomes, while also fulfilling a purpose-led role in society.</p><p>
As <b>Local Study Associate Director, </b>you will lead Local Study Teams(LST) at the country level to deliver clinical studies according to agreed resources, budget, and timelines complying with procedural documents, international guidelines as well as relevant local regulations.</p><p>
In addition to leading LST(s), the Local Study Associate Director (LSAD) may</p><p>
visit site as needed to support the flexible capacity model.</p><p>
The LSAD is responsible for ensuring that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.</p><ul><li><p>
Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA</p></li><li><p>
Lead Local Study Team(s) consisting of CRAs, start-up specialists, and study administrator(s).</p></li></ul><p><b>
ESSENTIAL REQUIREMENTS</b></p><ul><li><p>
Bachelor&rsquo;s degree in a related discipline, preferably in life science, or equivalent qualification.</p></li><li><p>
Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).</p></li><li><p>
Experience of ICF preparation essential.</p></li><li><p>
Experience of leading clinical trials.</p></li><li><p>
At least 1 years project management experience is a key requirement.</p></li><li><p>
Good knowledge of international guidelines ICHGCP as well as relevant local regulations.</p></li><li><p>
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.</p></li><li><p>
Excellent project management skills.</p></li></ul><p><b>
Apply today!</b></p><p>
#LI-TA1</p><br>
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Local Study Associate Director - FSP

<div><p>Parexel FSP is hiring Local Study Associate Directors to join us on a</p><p>
permanent full-time, home-based basis.</p><p></p><p>
The role requires working in a hybrid model, with 3 days/week at the sponsors office (Istanbul, Ankara, or Izmir).</p><p></p><p>
If you&rsquo;re driven by the potential of science to create meaningful change and</p><p>
eager to explore your capabilities, join us.</p><p></p><p>
Dedicated to a single sponsor in BioPharma, who is revolutionizing healthcare by harnessing the power of science to benefit people, society, and the planet. Turkey is a vital part of their global network, hosting colleagues from every segment of the life sciences value chain. Their science-driven approach aims to transform healthcare and improve patient outcomes, while also fulfilling a purpose-led role in society.</p><p></p><p>
As <b>Local Study Associate Director, </b>you will lead Local Study Teams(LST) at the country level to deliver clinical studies according to agreed resources, budget, and timelines complying with procedural documents, international guidelines as well as relevant local regulations.</p><p></p><p>
In addition to leading LST(s), the Local Study Associate Director (LSAD) may</p><p>
visit site as needed to support the flexible capacity model.</p><p></p><p>
The LSAD is responsible for ensuring that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.</p><ul><li><p>
Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA</p></li><li><p>
Lead Local Study Team(s) consisting of CRAs, start-up specialists, and study administrator(s).</p></li></ul><p></p><p><b>
ESSENTIAL REQUIREMENTS</b></p><ul><li><p>
Bachelor&rsquo;s degree in a related discipline, preferably in life science, or equivalent qualification.</p></li><li><p>
Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).</p></li><li><p>
Experience of ICF preparation essential.</p></li><li><p>
Experience of leading clinical trials.</p></li><li><p>
At least 1 years project management experience is a key requirement.</p></li><li><p>
Good knowledge of international guidelines ICHGCP as well as relevant local regulations.</p></li><li><p>
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.</p></li><li><p>
Excellent project management skills.</p></li></ul><p></p><p><b>
Apply today!</b></p><p></p><p>
#LI-TA1</p><br>
<p></p>
#LI-REMOTE</div>

<div><p>Parexel FSP is hiring Clinical Research Associates, from all levels to join us on a permanent full-time, home-based basis.</p><p></p><p>
Dedicated to a single sponsor in BioPharma, who is revolutionizing healthcare by harnessing the power of science to benefit people, society, and the planet. Turkey is a vital part of their global network, hosting colleagues from every segment of the life sciences value chain. Their science-driven approach aims to transform healthcare and improve patient outcomes, while also fulfilling a purpose-led role in society.</p><p></p><p><b>
Job Purpose</b>:</p><p>
As a Clinical Research Associate (CRA)/Clinical Monitor, you will have local responsibility for the delivery of the studies at allocated sites and will be an active participant in the local study team(s). You will work in close collaboration with other Monitors and the Local Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. You will be the main contact with the study site and will have responsibility for the proper conduct of the study.</p><p></p><p>
The CRA is responsible for the preparation, initiation, monitoring, and closure of an agreed number of centers in clinical studies according to Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations, and that the centers deliver according to the commitment in the individual trials.</p><p></p><p>
A CRA with longer tenure and experience may take on additional responsibilities, including tasks associated with the Local Study Manager.</p><p></p><p>
Requirements:</p><ul><li><p>
Minimum 18 months of experience as a Clinical Research Associate conducting all visits.</p></li><li><p>
Experience gained ideally in Pharma, CRO, or Biotech.</p></li><li><p>
Good understanding of Clinical Study Management including monitoring, study drug handling, and data management.</p></li><li><p>
Bachelor&rsquo;s degree in a related discipline, preferably in life science, or equivalent qualification.</p></li><li><p>
Strong oncology experience.</p></li></ul><p></p><p>
Apply today!</p><p></p><p>
#LI-TA1</p><br>
<p></p>
#LI-REMOTE</div>

Clinical Research Associates - ALL LEVELS FSP /Single sponsor/Turkey

<div></div><div><div><p>Parexel FSP is hiring Clinical Research Associates, from all levels to join us on a permanent full-time, home-based basis.</p><p>
Dedicated to a single sponsor in BioPharma, who is revolutionizing healthcare by harnessing the power of science to benefit people, society, and the planet. Turkey is a vital part of their global network, hosting colleagues from every segment of the life sciences value chain. Their science-driven approach aims to transform healthcare and improve patient outcomes, while also fulfilling a purpose-led role in society.</p><p><b>
Job Purpose</b>:</p><p>
As a Clinical Research Associate (CRA)/Clinical Monitor, you will have local responsibility for the delivery of the studies at allocated sites and will be an active participant in the local study team(s). You will work in close collaboration with other Monitors and the Local Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. You will be the main contact with the study site and will have responsibility for the proper conduct of the study.</p><p>
The CRA is responsible for the preparation, initiation, monitoring, and closure of an agreed number of centers in clinical studies according to Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations, and that the centers deliver according to the commitment in the individual trials.</p><p>
A CRA with longer tenure and experience may take on additional responsibilities, including tasks associated with the Local Study Manager.</p><p>
Requirements:</p><ul><li><p>
Minimum 18 months of experience as a Clinical Research Associate conducting all visits.</p></li><li><p>
Experience gained ideally in Pharma, CRO, or Biotech.</p></li><li><p>
Good understanding of Clinical Study Management including monitoring, study drug handling, and data management.</p></li><li><p>
Bachelor&rsquo;s degree in a related discipline, preferably in life science, or equivalent qualification.</p></li><li><p>
Strong oncology experience.</p></li></ul><p>
Apply today!</p><p>
#LI-TA1</p><br>
#LI-REMOTE
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Join Parexel and explore 6   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Parexel

ABOUT_COMPANY

Senior Clinical Research Associate

Regulatory Affairs Consultant (Biologics/Small Molecules)

Local Study Associate Director - FSP

Local Study Associate Director - FSP

Clinical Research Associates - ALL LEVELS FSP /Single sponsor/Turkey

Clinical Research Associates - ALL LEVELS FSP /Single sponsor/Turkey