Allucent

Allucent is a global Clinical Research Organization focused on helping small and mid-sized biotech companies navigate drug development challenges. With over 30 years of experience across 60 countries, it offers comprehensive solutions in consulting, clinical operations, biometrics, and clinical pharmacology, emphasizing individualized partnerships and high-quality customer service.

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🏢 Precision Medicine Group

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🔥 Director, Project Management (GOV'T)

Posted 2024-11-23

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🔥 Senior CRA (Australia)

Posted 2024-11-23

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🔥 Clinical Trial Associate (LATAM)

Posted 2024-11-21

📍 Brazil, Mexico

🔍 Biopharmaceutical

High School Diploma/Certificate or equivalent combination of education, training, and experience; preferred Bachelor's degree.
Knowledge of Good Documentation Practices.
Knowledge of Good Clinical Practices.
Strong command of English language, both written and verbal.
At least 1 year of experience in clinical research on CRO side preferred.
Experience using eTMF, ISF/ISP preferred.
Excellent communication, organizational, and listening skills.
Ability to confront constructively and foster learning.
Representative, outgoing, and client-focused.
Effective organizational, managerial, and time management skills.
Strong analytical and problem resolution skills.
Demonstrated ability to lead by example and maintain integrity.
Ability to establish effective working relationships.
Ability to work in a fast-paced environment.
Proficiency with computer applications like Word, Excel, and PowerPoint.

Perform quality check of documents prior to eTMF submission to ensure completeness and accuracy.
Act as Document Submitter for country and site level documents in eTMF and resolve rejections.
Assist with resolution of periodic QC findings for country and site eTMF.
Maintain study wet-ink documents temporarily and prepare shipment to clients at study end.
Communicate with the TMF Lead/Project Specialist on eTMF status.
Update Expected Documents List in eTMF.
Maintain Public Folders according to Study Correspondence Management Plan.
Prepare and distribute Investigator and Pharmacy Site Files for Site Initiation Visits.
Maintain QC/Inventory Checklists to support CRA during site visits.
Assist CRA with reconciliation of ISF/PSF vs. TMF for inspection readiness.
Assist CRAs/CTLs with query resolution and action item metrics follow up.
Perform translations or verification of study documentation as needed.
Update and maintain site level CTMS.

LeadershipCollaborationMentoringTime ManagementDocumentation

Posted 2024-11-21

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🔥 Sr. Director, Biostatistical Consulting

Posted 2024-11-13

📍 Canada

🧭 Full-Time

🔍 Biopharmaceutical

Graduate degree in statistics, mathematics, life science, epidemiology, or healthcare.
Minimum 15 years of relevant work experience, with at least 10 years in drug development or clinical research.
Thorough knowledge of GxP and relevant regulations, including GDPR/HIPPA and CFR/CTR/CTD.
Strong skills in SAS and/or other statistical programming languages, and proficiency with sample size software.
Excellent communication skills, both written and verbal, with an emphasis on collaboration and client focus.

Provide statistical consulting to sponsors to support clinical program development, protocol development, and sample size calculations.
Lead complex statistical analyses and provide input on regulatory questions related to submissions.
Prepare statistical analysis plans (SAPs) and review statistical documents ensuring quality and integrity.
Act as the lead statistician on studies, manage unblinded tasks, and ensure collaboration across functional areas.
Maintain strong relationships with clients and participate in marketing activities.

LeadershipSAPCommunication SkillsCollaborationProblem SolvingMentoringAttention to detailCompliance

Posted 2024-11-13

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🔥 Pharmacovigilance (LCPPV) - Freelance

Posted 2024-11-07

📍 Czechia, Croatia, Poland, Latvia, Cyprus

🧭 Freelance

🔍 Biopharmaceutical

University degree, preferably in medicine, pharmacy, or life sciences.
Minimum 2 years of experience in pharmacovigilance post-marketing activities.
Up-to-date knowledge of global and local regulatory requirements.
In-depth knowledge of the pharmacovigilance legal framework in the service country.
Fluency in written and spoken English.
Must reside in the country where LCPPV provides services.

Acts as the primary contact for local regulatory authorities, including 24/7 availability if legally required.
Monitors local legislation and safety issues related to pharmacovigilance.
Supports audits and inspections, providing documentation and completing CAPAs as needed.
Involves local literature screening, safety information collection, and local submissions.
Responsible for local signal detection and managing risk minimization measures.
Reports to and communicates regularly with the EU QPPV.
Conducts local PV training and provides monthly activity reports on the local PV system.

Communication SkillsAnalytical SkillsCollaborationProblem SolvingAttention to detailOrganizational skillsTime ManagementWritten communicationMultitasking

Posted 2024-11-07

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🔥 Associate Director, Biostatistical Consulting

Posted 2024-11-07

📍 United States

🧭 Full-Time

🔍 Biopharmaceutical

Graduate degree in statistics, mathematics, life science, epidemiology, or healthcare.
Minimum 12 years of work experience and 6 years in drug development or clinical research.
Good knowledge of GxP and familiarity with relevant regulations like GDPR, HIPAA.
Proficient in SAS and sample size software, with strong technical, analytical, and problem-solving skills.
Excellent organizational skills, detail-oriented, and capable of managing multiple tasks.

Support and provide statistical consulting services for clinical program and protocol development.
Contribute to client executive decisions and regulatory submissions, interacting with regulatory bodies.
Prepare statistical analysis plans and reviews to ensure document quality.
Lead projects by setting timelines, communicating with clients, and collaborating with teams.
Function as the lead statistician for studies and manage budget oversight.

LeadershipBusiness DevelopmentSAPBusiness developmentCommunication SkillsCollaboration

Posted 2024-11-07

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🔥 Sr. Clinical Trial Leader (Australia)

Posted 2024-10-15

📍 Australia

🧭 Full-Time

🔍 Biopharmaceuticals

A bachelor's degree in life sciences or nursing qualification preferred.
A minimum of 6 years clinical research experience with at least 2 years CTL or CTM.
Ability to mentor and train other CRAs.
In-depth knowledge of clinical trials and critical elements for success.
Strong therapeutic background.
Experience and knowledge in the CRO industry.
Ability to successfully manage people/project issues.
Mature management skills demonstrated by thorough review of situations.
Proactively identifies and addresses problems.
Ability to define and meet project requirements.
Flexibility for improvement and creating solutions.
Proven organizational abilities.
Excellent written and oral communication skills.
Excellent team player with team building skills.
Strong customer focus.

Manage the study start up in collaboration with PM, Regulatory Lead, and if applicable, Global Site Activation Manager (GSAM).
Coordination and oversight of Critical documentation collection, maintenance, and filing.
Preparing Monitoring Plan; providing input to TMF Plan and to other study plans. Ensure all plans are implemented.
Contributes to the development of CRF guidelines and edit checks.
Selecting 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.
Manage successful trial close-out and identify activities for timely 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 CRMs/COMs.
Coordinate and manage site visit schedules.
Manages CRA site assignments and schedules.
Develop patient recruitment and retention plans.
Provide project updates to PM for Project Review Meetings and attend if needed.
Conduct project co-monitoring and team training.
Site contact for protocol clarifications and subject enrollment if CRA is unavailable.
Monitor and manage trial materials supplies.
Review data listings and query reports to identify trends.
Oversee protocol deviation documentation, tracking, and escalation.
Participate in developing study newsletters communication.
Relay project status and issues to PM.
Request appropriate Clinical Operations staffing and report study deliverables and resources.
Assist PM in client discussions about study documentation issues.
Review study systems updates regularly to ensure correctness.
Coach/mentor CRA team and develop project-specific training.
Ensure project consistency within SOPs.
Assist in revising Site Budgets and managing Investigator and Site Payments.
Contribute to case management and timely closure.
Support PM in managing study vendors as required.
Provide input into proposals when required.
Actively participate in the preparation and presentation of bid defense or study-related meetings.

LeadershipProject ManagementPeople ManagementProject CoordinationCross-functional Team LeadershipCommunication SkillsAnalytical SkillsCollaboration

Posted 2024-10-15

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🔥 Clinical Research Associate I/II

Posted 2024-10-15

📍 Australia

🧭 Full-Time

🔍 Clinical Research

At least 2 years of experience in Clinical Research Operations and onsite monitoring.
Skills to mentor and train other CRAs effectively.
In-depth knowledge of clinical trials.
Strong therapeutic background.
Ability to manage people and project issues.
Mature management skills with problem identification and resolution skills.
Ability to define and meet project requirements.
Flexibility and creativity in problem-solving.
Proven organizational, written, and oral communication skills.
Strong teamwork and customer focus.
Knowledge of regulatory submission and reporting requirements.
Understanding of the drug development process.

Governs quality standards for trial monitoring activities.
Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites.
Monitors activities to ensure adherence to GCP, ICH, SOPs, and study protocols.
Tracks ongoing study data for project status reporting.
Collects and reviews regulatory documents as needed.
Prepares site visit and contact reports.
Maintains and updates CTMS in compliance with SOPs.
Acts as Document Owner for collected documents.
May assist in the start-up process and prepare necessary documentation.
Proactively addresses site issues and recruitment challenges.
Collaborates with the Centralized Monitoring Team for risk evaluations.
Ensures maintenance of the Trial Master File and Investigator Site File.
Assists the Project Manager and Clinical Team Leader with forms and regulatory document authorization.

LeadershipProject ManagementProject CoordinationCross-functional Team LeadershipCommunication SkillsAnalytical SkillsCollaborationMentoring

Posted 2024-10-15

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🔥 Associate Director, Biostatistical Consulting (Canada)

Posted 2024-10-15

📍 Canada

🧭 Full-Time

🔍 Biopharmaceutical

Graduate degree (Master’s degree/local equivalent, or higher) in a relevant discipline including, but not limited to, statistics, mathematics, life science, epidemiology, or healthcare
Minimum 12 years of relevant work experience
Minimum 6 years of experience in drug development and/or clinical research
Good knowledge of GxP
Strong familiarity with relevant regulations and guidelines
GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements
Working knowledge of computer systems, applications and operating systems
Demonstration of critical thinking and analytic skills
Broad knowledge of drug development
Ability to simplify complex issues into understandable concepts
Proficient with one or more sample size software packages
Strong technical skills with proficiency in SAS and/or other statistical programming languages
Strong written and verbal communication skills including good command of English language
Collaborative and client-focused
Ability to work in a fast-paced challenging environment of a growing company
Administrative excellence
Strong leadership skills
Effective at problem solving, strategic thinking and conflict resolution
Strong presentation and networking capabilities
Excellent organizational, negotiating and financial skills
Knowledge of SAS
Proficiency with various computer applications such as Word, Excel, and PowerPoint
Strong individual initiative
Excellent attention to detail and commitment to quality
Ability to establish and maintain effective working relationships with co-workers, managers, clients, and vendors
Ability to effectively manage multiple tasks and projects
Reputation as a leader with sustained performance and accomplishment

Support and/or provide statistical consulting services provided to sponsors to support clinical program development, protocol development, sample size calculations, endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions
Support and/or provide statistical consulting for complex and/or novel statistical analyses
Contributes statistical consulting to support clinical development strategies, including support for client executive and leadership teams
Provide input and support responses to regulatory questions on statistical issues relating to client regulatory submissions, interacting with and attending meetings with regulatory bodies as applicable
Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for any complexity of study
Provide senior reviews of statistical documents, data, and outputs for studies of all complexities to ensure quality and integrity
Execute a statistical analysis of any complexity as specified in a protocol or analysis plan · Interpret and communicate results for complex statistical analyses and outputs
Develop and/or review the statistical sections of a study protocol for studies of any complexity level
Review statistical sections of a clinical study report to ensure accurate descriptions of statistical methods used and results of analyses
Provide randomization materials including randomization schedules and treatment kit lists per Allucent SOPs and the sponsor-approved specifications
Develop or review documents for integrated analyses (e.g. ISS/ISE), including integrated SAPs and statistical sections of integrated study reports
Working knowledge of SAS® for production and validation of datasets and statistical outputs
Write and review specifications for complex ADaM or analysis datasets
Annotate or review annotations of TLF mocks to assist programming efforts
Working knowledge of CDISC standards
Review CRF design to ensure it conforms with the study protocol and analysis needs
Review data management documents as requested to ensure integrity of study data
Lead highly complex projects by fulfilling the following responsibilities: communicate with the client and statistical team, set and achieve timelines and milestones, ensure proper execution of the study SAP, monitor programming efforts in collaboration with the lead programmer, and work with management to ensure adequate resourcing
Function as the lead unblinded statistician for studies and manage unblinded tasks including implementation of interim analyses and participation in DMC/safety review meetings
Accountable for leading biostatistics and programming activities for a program of studies of high complexity and/or of high value
Identify high-risk or high-impact deliverables and assign appropriate oversight
Manage project budgets, support financial reporting for studies, identify of out-of-scope work and provide support for the change order process
Collaborate with and verify open communication with other functional areas and business units
May provide biometrics leadership and coordination across client and other vendor functional areas, including clinical operations, pharmacovigilance, regulatory, and medical writing teams
May have line management and mentoring responsibilities
May represent Allucent at proposal bid defenses and/or marketing meetings with prospective clients and participate in other activities via blogs, webinars, white papers and other publications / presentations
Contribute to other areas of business and assignments as required

LeadershipBusiness DevelopmentSAPBusiness developmentCommunication SkillsCollaboration

Posted 2024-10-15

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🔥 Global Feasibility Manager

Posted 2024-10-15

📍 Brazil, Canada

🧭 Full-Time

🔍 Biopharmaceutical

Bachelor's Degree in a life sciences field is required.
Master's Degree or Ph.D. in Healthcare or Biological Science is preferred.
Minimum of 5 years of experience in drug development and/or clinical research or equivalent.
Minimum 5 years of Global Feasibility & Site Identification experience; experience in strategic feasibility preferred.
Basic knowledge of ICH-GCP, GDPR/HIPPA, CFR/CTR/CTD and applicable regulatory requirements.
Demonstrable experience with analytics involving large datasets.
Strong written and verbal communication skills including good command of English.
Representative, outgoing, and client-focused.
Demonstrated knowledge of government/international databases, open-source databases or proprietary ones.
Ability to interpret data sources and provide clear recommendations.
Ability to form strong working relationships with other groups.
Ability to work in a fast-paced environment.
Administrative excellence.
Proficiency with Word, Excel, and PowerPoint.

Provide input to proposals and business development to help build project assumptions, budget, and timelines.
Identify and present regions where the disease is prominent to create an initial country pool.
Identify the incidence and prevalence of the disease / syndrome.
Analyze competing clinical trial landscape to assess study feasibility and identify barriers for enrollment.
Access databases to determine similar patient populations or therapeutic classes.
Determine whether proposed countries have comparator drug access/reimbursement.
Represent Allucent’s expertise by presenting study footprint in the indication.
Work with Allucent’s medical experts / KOLs on study conduct and acceptance.
Collaborate with Global Study Start-Up to determine strategy, regulatory pathway, and timelines.
Conduct post-award feasibility studies with potential sites.
Write or oversee feasibility reports for clients as required.
Present and explain feasibility analysis to BD/Clients.
Provide input on patient recruitment & retention strategies.
Maintain internal libraries and databases related to feasibility.
Expand and maintain site and investigator network.
Assure effective interface of the Feasibility function with other key departments.
Review and approve reports and manuscripts as necessary.
Maintain current knowledge of regulations, guidelines, and technologies.

Business DevelopmentGCPStrategyBusiness developmentCommunication SkillsCollaboration

Posted 2024-10-15

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Allucent

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