Qureos Mentor

Parexel

<div>The Junior Study Start-up Specialist is responsible for conducting and facilitating specific start-up activities that may include but is not limited to handling Confidentiality Agreements, processing feasibility questionnaire, essential document collection and review, ICF customization, coordination of EC and CA submissions. This role brings regulatory, timeline or other concerns to the attention of the Global Study Start-Up Lead and/or Project Team and actively participates in finding solutions. As a member of this team, you will be essential to ensuring our Investigator sites are prepared to start trials, with a focus on reducing Site Activation timelines.
Assures that SSU functions interface effectively with all other key operating working with e.g., Clinical Operations, SSU specialists, Regulatory and contract vendor on project specific status and deliverables.
Key Accountabilities: 
Oversight of activities:<ul><li>
Collation and tracking of site feasibility.</li><li>
Responsible for ensuring CDA is in place.</li><li>
Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information within JVRIM/CTIS, and similar information for other related organizations, for the assigned country e.g., IRAS</li><li>
Responsible for ensuring clinical trial insurance is in place for submission.</li><li>
Responsible for the translation and co-ordination of translations for documents required for submission.</li><li>
Creation, review, and customization of country/site specific Informed Consent Forms (ICFs)</li><li>
Works with regulatory team members and SSU Lead to secure authorization of regulatory documents.</li><li>
Works with legal, contract vendor and SSU Lead to secure authorization of contracts.</li><li>
Collects and reviews initial regulatory packets and site contracts for investigator sites.</li><li>
Coordinate efforts for all site activation related activities including but not limited to obtaining and maintaining regulatory and ethics approvals, review, and approval of essential documents for IP Release</li><li>
Prepares ongoing submissions, amendments, and periodic notifications required by central and local IRB/EC, CA, and other local regulatory authorities as needed within the country. Including safety notifications as required by local laws/guidelines.</li><li>
Ensures all relevant documents are submitted to the Trial Master File (TMF)</li><li>
Responsible for liaising with local CRA/CTM, Contract Vendor, and Regulatory Lead to enable a rapid clinical trial start up.</li><li>
Inform team members of completion of regulatory and contractual documents for individual sites.</li><li>
Attend project meetings with cross functional department leads to provide updates.</li><li>
Identify site issues (risks) during start-up process; resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.</li><li>
Escalate risks (e.g. timelines, etc.) to SSU Lead or CTM, as appropriate.</li><li>
Reviews and provide feedback to SSU Lead on site performance metrics.</li><li>
Maintains and manages SSU data tracking entries, reviews for completeness and accuracy.</li><li>
Facilitates process improvement efforts both within the department and in cooperation with other departments.</li><li>
Support the development of start-up plans and essential document checklists</li></ul>
Collaborative relationships<ul><li>
Collaborates effectively with cross-functional teams, including regulatory, legal, and clinical operations to manage site start-up activities, ensure compliance with regulatory requirements, and facilitate efficient clinical trial initiation that aligns with project timelines and quality standards.</li></ul>
Skills:<ul><li>
Ability to work independently in a fast-paced environment.</li><li>
Ability to identify and resolve site issues independently, and effectively escalate complex problems when necessary, contributing to efficient risk management.</li><li>
Displays flexibility and willingness to support process improvement efforts, adapting to changing requirements and collaborating across departments to enhance overall efficiency.</li><li>
Excellent verbal and written communication skills, with the ability to effectively liaise with diverse stakeholders, including CRAs, CTMs, regulatory authorities, and cross-functional team members.</li></ul>
Knowledge and Experience:<ul><li>
Pharmaceutical or related industry experience</li><li>
Previous experience of working in a Start-up team, as a Clinical Trial Specialist, or similar role, having worked on global clinical trials.</li><li>
Experience of in-house trials/process design are beneficial</li><li>
Excellent knowledge of GCP and regulations</li></ul>
Education:<ul><li>
Bachelor&rsquo;s Degree or 3 years&rsquo; clinical research or other relevant experience; or equivalent combination of education, training, and experience.</li></ul> 

#LI-REMOTE</div>

Study Start Up Specialist- FSP

<div>Remote position- can be US or Canada*******
The Senior Manager, Site Start Up will oversee a portfolio of client studies where the client have given operational responsibility to our CRO partners for trial execution. As an expanding capability, the Senior Manager, Site start Up will support development of infrastructure, processes, teams and appropriate technology to assist in the effective oversight of out- sourced studies. Additionally, this role will work collaboratively with the CRO project teams to maintain timelines and ensure that start-up activity is progressing as expected per the startup plan. Where delays occur, they will work with the Project Teams/Oversight Manager to mitigate delays and risks and ensure alternative plans for maintaining start up delivery are implemented. May manage a team of Oversight Managers (e.g., regional allocations) to support program delivery with our CRO partners in successful execution of awarded studies. This new capability will accelerate trial set up, allow more confidence in trial enrolment, and improve our timelines for execution. Ultimately the group will increase the quality, improve speed and efficiency of our clinical trials execution.
Key Accountabilities: 
 
 Oversight of activities<ul><li>
Accountable for advancing study start-up activities for outsourced trials by understanding the objectives and assisting in the review and approval of the plan for country and site activation.</li><li>
Laser focus approach to oversight of startup activities within our CRO assigned programs. Working with the CRO partners to maintain timelines and successful execution.</li><li>
Accountable for all matters related to CRO partners study start-up requirements and must be able to communicate issues effectively to CRO counterpart and colleagues (e.g., CTM) as required.</li><li>
Adopting a unique start-up methodology to drive site activations through oversight of all activities, driving delivery and compliance across the assigned regions and CRO partners</li><li>
Leads day to day project activities in the matrix, by working closely with the Clinical Trial Manager and CRO counterparts.</li><li>
Accountable for advancing study start-up activities for outsourced trials by understanding the objectives and assisting in the review and approval of the plan for country and site activation.
</li><li>Laser focus approach to oversight of startup activities within our CRO assigned programs. Working with the CRO partners to maintain timelines and successful execution.
</li><li>Accountable for all matters related to CRO partners study start-up requirements and must be able to communicate issues effectively to CRO counterpart and colleagues (e.g., CTM) as required.
</li><li>Adopting a unique start-up methodology to drive site activations through oversight of all activities, driving delivery and compliance across the assigned regions and CRO partners
</li><li>Leads day to day project activities in the matrix, by working closely with the Clinical Trial Manager and CRO counterparts.</li></ul> 
Collaborative relationships<ul><li>
Collaborates effectively with cross-functional teams, CRO partners, and regional colleagues to advance study start-up activities, oversee site activation processes, and ensure timely execution of clinical trials that align with project objectives and regulatory requirements across diverse global landscapes.</li></ul> 
Compliance with Parexel standards<ul><li>
Complies with required training curriculum</li><li>
Completes timesheets accurately as required</li><li>
Submits expense reports as required</li><li>
Updates CV as required</li><li>
Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements</li></ul>
Skills:<ul><li>
Demonstrates ability to analyze complex situations, develop comprehensive plans, and oversee their execution across multiple partners and regions.</li><li>
Excels in building and maintaining productive relationships with diverse teams and stakeholders, both internal and external.</li><li>
Applies expertise to define scope, set timelines, monitor progress, and solve challenges in complex, multi-faceted projects.</li><li>
Exhibits strong ability to lead in a matrix environment, communicate effectively at all levels, and present complex information to various stakeholders.</li></ul> 
Knowledge and Experience:<ul><li> 
Extensive pharmaceutical or related industry experience</li><li>
Extensive previous experience of working in a Start-up team, Clinical Trial Specialist, CRA, Clinical Trial Manager or similar having worked on global clinical trials.</li><li>
Experience in project management, CRO experience, change management or process design are beneficial</li><li>
The candidate must have a good working knowledge of clinical operations, clinical processes and medical terminology.</li><li>
Excellent knowledge of GCP and regulations</li><li>
Experience of controlled drug substances processed would be beneficial</li><li>
Experience of developing junior members of staff would be beneficial</li><li>
Experience of Regulatory Inspections</li></ul> 
Education:<ul><li> 
Degree (BSc) or equivalent experience gained through time in industry (&gt;5yrs)</li></ul>
#LI-LG4 
#LI-REMOTE</div>

Senior Manager, Study Start Up - FSP

<div>Key Accountabilities:<div><div><div><div><div><div><div><div><div>
Site Management Responsibilities<ul><li>
Contributes to the selection of potential investigators.
</li><li>In some countries, as required, Sr CRAs 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.
</li><li>Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
</li><li>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.
</li><li>Actively participates in Local Study Team (LST) meetings.
</li><li>Contributes to National Investigators meetings, as applicable.</li><li>
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.
</li><li>Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
</li><li>Updates CTMS and other systems with data from study sites as per required timelines.
</li><li>Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.</li><li>
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.
</li><li>Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
</li><li>Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
</li><li>Ensures data query resolution in a timely manner.
</li><li>Works with data management to ensure robust quality of the collected study data.
</li><li>Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.</li><li>
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.
</li><li>Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
</li><li>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.
</li><li>Assists site in maintaining inspection ready ISF.
</li><li>Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
</li><li>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.
 </li><li>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.
</li><li>Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
</li><li>Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager</li></ul>
Compliance with Sponsor Standards<ul><li>
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).</li><li>
Ensures compliance with local, national, and regional legislation, as applicable.
</li><li>Completes timesheets accurately as required</li></ul>
Compliance with Parexel Standards<ul><li>
Complies with required training curriculum.
</li><li>Completes timesheets accurately as required.
</li><li>Submits expense reports as required.
</li><li>Updates CV as required.
</li><li>Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.</li></ul>
Skills (Essential):
<ul><li>Excellent attention to detail.
</li><li>Good written and verbal communication skills.
</li><li>Good collaboration and interpersonal skills.
</li><li>Good negotiation skills.
</li><li>Proficient in written and spoken English language required.
</li><li>Fluency in local language(s) required.
</li></ul>Skills (Desirable):
<ul><li>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.
</li><li>Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
</li><li>Good analytical and problem-solving skills.
</li><li>Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
</li><li>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.
</li><li>Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential):
</li><li>Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. &bull; Good knowledge of relevant local regulations.
</li><li>Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
</li><li>Basic understanding of the drug development process.
</li><li>Good understanding of Clinical Study Management including monitoring, study drug handling and data management.</li></ul>
Knowledge and Experience (Desirable):
<ul><li>Familiar with risk-based monitoring approach including remote monitoring.
</li><li>Good cultural awareness.
</li></ul>Education:
<ul><li>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.</li></ul>
Other:<ul><li>
Ability to travel nationally/internationally as required.
</li><li>Valid driving license per country requirements, as applicable</li></ul></div></div></div></div></div></div></div></div></div></div>

Senior Clinical Research Associate & CRAII - FSP (Open)

<div>Key Accountabilities:
The Biostatistician II works independently in the programming and quality control of derived datasets and all kind of statistical outputs (eg, tables, listings and figures), works under the supervision of an experienced biostatistician in the production of analysis plans and reports, provides basic statistical advice to clients and fulfils the project primary role within a designated project team.
Operational Execution<ul><li>
Production and/or QC of derived datasets and both simple and advanced statistical outputs using efficient programming techniques</li><li>
Understand and apply moderately advanced statistical methods</li><li>
Coordinate and lead a project team to successful completion of a project within given timelines and budget</li><li>
Interact with clients as key contact with regard to statistical and contractual issues</li><li>
Assist in the production of analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents</li><li>
Check own work in an ongoing manner to ensure first-time quality</li><li>
Provide training in statistical analysis to internal clients</li><li>
Proactively participate in and/or lead process/quality improvement initiatives</li><li>
Travel to, attend and actively contribute to all kind of client meetings as appropriate (eg discussing analysis concepts, presenting and discussing study results</li></ul>
General Activities<ul><li>
Mentor and train junior members of the department</li><li>
Additional responsibilities as defined by supervisor/manager</li></ul>
Business Development<ul><li>
Support of Business Development, eg by attending and preparing bid defense meetings</li></ul>
Skills:<ul><li>
Good analytical skills</li><li>
Good project management skills</li><li>
Professional attitude</li><li>
Attention to detail</li><li>
A good understanding of statistical issues in clinical trials</li><li>
Prior experience with SAS programming desirable</li><li>
Ability to work independently</li><li>
Good mentoring/leadership skills</li></ul>
Knowledge and Experience:<ul><li>
PhD in Statistics or related discipline entry level, MS in Statistics or related discipline with some experience</li><li>
The knowledge of pharmacokinetic data is an advantage</li><li>
Competent in written and oral English in addition to local language</li></ul>
Education:
<ul><li>PhD in Statistics or related discipline, MS in Statistics or related discipline</li></ul> 
#LI-REMOTE</div>

Biostatistician II

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ABOUT_COMPANY

Study Start Up Specialist- FSP

Senior Manager, Study Start Up - FSP

Senior Clinical Research Associate & CRAII - FSP (Open)

Biostatistician II