Clinical Trial Leader
4 tygodni temu
At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Clinical Trial Leader (CTL) to join our A-team (hybrid*/remote). As a Clinical Trial Leader at Allucent, you are responsible for providing leadership, management and oversight to the Clinical Research Associates (CRAs) and other clinical functional groups, in their day-to-day clinical trial activities on a global, multi-country, or regional basis. The CTL is responsible for coordinating and managing the planning, implementation, tracking, and ensuring the clinical deliverables as per the trial contract, budget, timelines and with quality. The CTL will perform tasks with minimal supervision whilst assisting, mentoring, and supporting the CRA teams.
In this role your key tasks will include:
Manages the trial start up and site activation in collaboration with PM, Global Regulatory Lead and, if applicable, Global Site Activation Manager (GSAM). Oversight of critical documentation collection, maintenance and filing. Develop the Monitoring Plan and site monitoring templates and tools. Provide input into Trial plans and tools (, protocol, Project Plan, Data Management Plan, eCRF Guidelines, TMF Plan, TMF Index, Risk Log, Recruitment Plan & trackers, Site Activation Management Plan, Regulatory and Ethics Submission Plan (RESP), Clinical Trial Agreement & Budget Plan (CTABP), Investigation Product Release Authorisation Plan (IPRAP), Trial Non-Compliance Management Plan, Medical Monitoring Plan, Safety Management Plan, Centralized Monitoring Plan, etc.) For trials with separate unblinded monitoring and when assigned unblinded CTL role, develops or assists the PM in the development of CRO Blinding Plan, Unblinding Plan and all necessary tools and templates for the unblinded monitoring and site activities. Reviews trial-specific documents upon request (, Protocol, Subject Information Leaflet/Informed Consent Forms, Laboratory Manual, Pharmacy Manual) Customises the annotated Site Visit Reports according to trial specific requirements. Selection of investigators and sites; SEV report review and approval. Site initiation management; SIV report review and approval Monitoring Visit Report (MVR) review, management, resolution and escalation. Manages successful trial close-out, identifies critical activities to make timely and efficient close-out. Responsible for timelines, budget and quality of Clinical Monitoring team deliverables, identification of risks and issues and escalation to PM, Line Manager, and GCO management . Coordinates and manages CRA site assignments, site visit schedules and site management activities. Provides information and input about planned activities and status to PM and attends Project Review Meetings if/when needed. Coaches/mentors CRA team. Provides performance feedback on team members as appropriate. Assists in developing and delivering project-specific training and provides input related to Project Specific Training Matrix. Prepares and chairs CRA calls and actively participates in internal trial team calls and client calls. Serves as a site contact for protocol clarifications and subject enrolment if CRA unavailable. Monitors and manages trial materials supplies. Ensures Investigational Product and other trial supplies are shipped to sites. Reviews data listings and query reports to identify trends and ensures proactive re-training is conducted with CRAs and site staff. Oversees the process of protocol deviation and Trial non-compliance documentation, tracking and escalation. Requests appropriate Clinical Operations staffing, workload and resources and reports trial deliverables and resource needs. Reviews trial systems (CTMS, CRF, IRS, central lab portal, etc.) updates on regular basis, ensures systems reports are up to date and reports generated are current and correct. Oversees eTMF status. Reviews trial reports and analyzes trends to recognize risks, provides input into mitigation plans and implements mitigations belonging to clinical activities Coordinates and provides support for trial related (site) audits & inspections Contributes to corrective and preventive action plans where needed and ensures their timely implementation and closure Assists in the preparation and conduct of Kick-Off Meetings, Investigators’ meetings and other committees’ or Trial meetings as requested. Prepares Country Level Site Facing Budgets and manages Investigator and Site Payments as applicable. Supports PM in the management of trial vendors as required. Project contract awareness and oversight; Forecast and report on the site management units throughout project life cycle, and identify changes in scope and liaise with the Project ManagerRequirements
To be successful you will possess:
A degree in life sciences or nursing qualification A minimum of 5 years clinical research experience with at least 2+ years as Lead CRA. In-depth knowledge of ICH GCP, clinical trials and the critical elements for success in clinical trials Strong therapeutic background Strong written and verbal communication skills including good command of English language Professional and strong client focused Ability to work in a fast-paced challenging environment of a growing company Administrative excellence with attention to detail and accuracy Leadership and mentoring skills. Excellent team player with team building skills Strong organizational skills to be able to manage a full workload across multiple projects. Ability to mentor and train other CRAs in a positive and effective manner Demonstrates flexibility for creating solutions and process improvement Analytical, financial and problem resolution skills Proficiency with various computer applications such as Word, Excel, and PowerPoint, CTMS, eTMF required Ability to successfully manage people/project issues Mature management skills demonstrated by calm and thorough review of situations. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate, creative resolutions. Demonstrates the ability to define and meet project requirementsBenefits
Benefits of working at Allucent include:
Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employeesDisclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our .
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
-
Clinical Trial Manager
4 tygodni temu
Warsaw, Polska IQVIA Pełny etatClinical Trial Management and Central Trial Oversight services provide for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and...
-
Clinical Trial Manager
3 tygodni temu
Warsaw, Polska IQVIA Pełny etatClinical Trial Management and Central Trial Oversight services provide for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and...
-
Clinical Operations Manager, Trial Management
3 tygodni temu
Warsaw, Polska Novo Nordisk AS Pełny etatDo you want to be part of a dynamic team, working in an international environment that drives clinical trial activities? Do you want to develop further as a people manager within the clinical trials field? Then keep reading - we may have just the right job for you! Clinical Development Centre (CDC) Poland is expanding and is looking for a new Clinical...
-
Clinical Operations Manager, Trial Management
3 tygodni temu
Warsaw, Polska Novo Nordisk Pełny etatThe position will be based in Warsaw and reporting to the CDC Therapy Area Head, Obesity Unit. While your focus is on People Management activities, your responsibilities will also include maintaining the best-in-class trial execution and quality through the following: Give input to allocation of CTA resources. Drive continuous improvement initiatives...
-
Clinical Operations Manager, Trial Management
3 tygodni temu
Warsaw, Polska Novo Nordisk Pełny etatDo you want to be part of a dynamic team, working in an international environment that drives clinical trial activities? Do you want to develop further as a people manager within the clinical trials field? Then keep reading - we may have just the right job for you! Clinical Development Centre (CDC) Poland is expanding and is looking for a new Clinical...
-
Scientist, Clinical Trial Safety
4 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatABOUT DEPARTMENT The Trial Safety Review Center (TRISARC) is a department in the Research and Development function of AstraZeneca. The primary remit of the TRISARC is to review large amounts of clinical (mainly safety) data flowing through the clinical trial environment in order to ensure patient data is complete and medically accurate thus allowing...
-
Analyst, Clinical Trial Transparency, Anonymization
3 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatThe Clinical Transparency & Data Sharing team is within CMO office and leads the AstraZeneca Group of Companies, Clinical Trial Transparency Position Globally. We are responsible for clinical data sharing, clinical document sharing and clinical transparency patient engagement activities such as the Lay Summaries and Thank you cards. The CTT Anonymization...
-
Analyst, Clinical Trial Transparency, Anonymization
4 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatThe Clinical Transparency & Data Sharing team is within CMO office and leads the AstraZeneca Group of Companies, Clinical Trial Transparency Position Globally. We are responsible for clinical data sharing, clinical document sharing and clinical transparency patient engagement activities such as the Lay Summaries and Thank you cards. The CTT Anonymization...
-
Warsaw, Polska AstraZeneca Pełny etatLocation : Warsaw (PL) Salary: Competitive, with excellent benefits. Hybrid model of work : 3 days in office, 2 days remote per week This role sits within the Clinical Document Anonymisation and Data Sharing function in Clinical Trial Transparency, Chief Medical Office. The Clinical Trial Transparency leads the AstraZeneca Group of Companies,...
-
Director Clinical Trial Transparency Anonymization
4 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatis a Typical accountabilities Ensures delivery of Anonymized and Redacted documents necessary to meet Health Canada PRCI, EMA policy 0070 and EMA EU CTR post MAA requirements Ensure AZ is using best in class tools to deliver Anonymized and Redacted documents. Expert in Measurement of patient reidentification threshold on clinical SAS datasets to...
-
CDC Trial Manager
1 miesiąc temu
Warsaw, Polska Novo Nordisk AS Pełny etatYou are applying to be a part of a Novo Nordisk Talent Pool (Pipeline), not a currently open position. Joining our pipeline means that you will be considered as a potential match for current and upcoming positions to ensure you don’t miss out on a life-changing career. When an opportunity arises, we will reach out and invite you for an interview. We will...
-
CDC Trial Manager
3 tygodni temu
Warsaw, Polska Novo Nordisk AS Pełny etatYou are applying to be a part of a Novo Nordisk Talent Pool (Pipeline), not a currently open position. Joining our pipeline means that you will be considered as a potential match for current and upcoming positions to ensure you don’t miss out on a life-changing career. When an opportunity arises, we will reach out and invite you for an interview. We will...
-
CDC Trial Manager
1 miesiąc temu
Warsaw, Polska Novo Nordisk Pełny etatThe position In the role of CDC Trial Manager you will be focusing on developing and executing all stages of the allocated Trial Strategic Plan on the CDC level. On a daily basis, you will manage allocated trials on CDC level to deliver the trials KPIs. You will also manage the CDC Trial Teams, establish and maintain professional relationships with...
-
CDC Trial Manager
3 tygodni temu
Warsaw, Polska Novo Nordisk Pełny etatThe position In the role of CDC Trial Manager you will be focusing on developing and executing all stages of the allocated Trial Strategic Plan on the CDC level. On a daily basis, you will manage allocated trials on CDC level to deliver the trials KPIs. You will also manage the CDC Trial Teams, establish and maintain professional relationships with...
-
Senior Analyst, Clinical Trial Transparency Anonymization
3 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatequire anassociated Typical Accountabilities and required competencies Create Anonymized Clinical Documents following best practices and established SOPs. Contribute to the Anonymization Report for the reports created. Be a system expert in the use of Technology Tool for delivery of Anonymized Clinical Documents. Perform System User Acceptance...
-
Senior Analyst, Clinical Trial Transparency Anonymization
4 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatequire anassociated Typical Accountabilities and required competencies Create Anonymized Clinical Documents following best practices and established SOPs. Contribute to the Anonymization Report for the reports created. Be a system expert in the use of Technology Tool for delivery of Anonymized Clinical Documents. Perform System User Acceptance...
-
Senior CDC Trial Manager
2 miesięcy temu
Warsaw, Polska Novo Nordisk AS Pełny etatYou are applying to be a part of a Novo Nordisk Talent Pool (Pipeline), not a currently open position. Joining our pipeline means that you will be considered as a potential match for current and upcoming positions to ensure you don’t miss out on a life-changing career. When an opportunity arises, we will reach out and invite you for an interview. We will...
-
Senior CDC Trial Manager
3 tygodni temu
Warsaw, Polska Novo Nordisk AS Pełny etatYou are applying to be a part of a Novo Nordisk Talent Pool (Pipeline), not a currently open position. Joining our pipeline means that you will be considered as a potential match for current and upcoming positions to ensure you don’t miss out on a life-changing career. When an opportunity arises, we will reach out and invite you for an interview. We will...
-
Senior CDC Trial Manager
2 miesięcy temu
Warsaw, Polska Novo Nordisk Pełny etatThe position In the role of CDC Senior Trial Manager you will be focusing on developing and executing all stages of the allocated Trial Strategic Plan on the CDC level. On a daily basis, you will manage allocated trials on CDC level to deliver the trials KPIs. You will also manage the CDC Trial Teams, establish and maintain professional relationships...
-
Senior CDC Trial Manager
3 tygodni temu
Warsaw, Polska Novo Nordisk Pełny etatThe position In the role of CDC Senior Trial Manager you will be focusing on developing and executing all stages of the allocated Trial Strategic Plan on the CDC level. On a daily basis, you will manage allocated trials on CDC level to deliver the trials KPIs. You will also manage the CDC Trial Teams, establish and maintain professional relationships...
