Clinical Trial Manager
- Employer
- STALICLA SA
- Location
- NY, New Jersey, Massachusetts, East Coast (Remote)
- Start date
- Apr 6, 2021
View more
- Discipline
- Clinical, Clinical Data, Clinical Development, Clinical Project Management, Clinical Research, Clinical Trials, Regulatory, Regulatory Affairs, Research/Documentation
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
As a rapidly growing company, STALICLA is currently expanding its team and is opening – for immediate entry – a Clinical Trial Manager position to reinforce its Clinical Development Team. He/She will work closely with the Senior Clinical Project Manager.
Responsibilities include but are not limited to:
Clinical trial overall:
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Develop and manage comprehensive study timelines and metrics (incl. budget development, timelines, milestones definition);
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Develop and manage study budget with financial goals;
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Prepare and present project debriefings, as required, plan, execute and lead or participate
in study specific meetings; Vendor Management:
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Identify and assist in selection of external vendors as required and in the development of vendor specifications;
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Track & manage study contracts to provide timely and accurate forecast;
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Ensure adequate study-specific training to clinical research staff;
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Lead and coordinate study-related vendors and serve as primary point of contact for
contracted CROs, study staff and contract labs;
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Identify potential risks and resolve issues with CROs while establishing vendor
management plans and reviewing quality metrics; Clinical site selection and management:
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Participate in site selection;
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Develop relationship with PI and site staff;
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Participate in the preparation of contracts;
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Prepare or participate in review site documents, including site specific informed consent
form, study tools/worksheets;
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Participate in site monitoring visits as appropriate;
Using your extended expertise in operational and knowledge of CNS, ideally neurodevelopmental disorders, optimize trial design and execution through:
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Design clinical trials protocols with Clinical team and consistent with clinical development plan;
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Prepare, or provide input on, study related documentation including CRFs, ICF template, monitoring templates, protocol worksheets, procedural manuals;
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Prepare and/or review study related documents, including monitoring plan, patient diary, clinical site procedures manual, pharmacy/laboratory manuals, CRF completion guidelines;
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Provide input and support documentation for AEs safety monitoring while collaborating with Clinical Team for regulatory authorities report submissions;
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Coordinate with CMC, clinical supply study drug manufacture, packaging, labeling, and distribution
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Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts;
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Review proposed study protocols to evaluate factors such as sample collection processes, data management plans;
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Communicating with laboratories or investigators regarding laboratory findings;
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Ensure trial execution as per international GCP guidelines, local regulations and SOPs;
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Participate in planning of QA activities, coordinate and ensure resolution of audit
findings;
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Ensure audit-ready clinical trial documentation including study-related files;
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Lead cross-functional study Team (internal and external) including CROs, vendors,
Clinical sites, Regulatory Affairs.
Requirements:
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C2 level or native English mandatory;
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Confirmed experience in Pharma/CRO industry with at least 6 years’ background in
Clinical Project Management, including prior experience managing contracted
resources/CRO;
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In depth know-how and strong experience in site monitoring and clinical data review;
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Excellent knowledge of clinical trial design and development;
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Good understanding/previous experience in regulatory affairs, documentation to FDA
(incl. IND);
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In depth knowledge of ICH-GCP, local legislation and procedures;
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Experience in management of study budget and contracts;
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Experience in risk assessment, development of mitigation plans and continuous review
and adjust plans as required;
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Highly motivated by clinical research in Neurodevelopmental Disorders – Results
oriented;
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Clinical research or pharmaceutical experience in CNS disorder, with in depth
understanding of early to late-phase clinical development programs;
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Training in Psychology or Neuropsychology with working knowledge of
neurodevelopmental disorder patients’ population preferred;
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Experience in pediatric programs is a plus;
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Excellent communication both orally and written;
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Respectful of deadlines;
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Proficiency in all of Microsoft Office;
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Hard working, driven to achieve creative and sound results.
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Good negotiation and communication skills;
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High performer with capacity to work autonomously;
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Flexibility to travel.
In addition, the candidates are expected to have:
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A high comfort level working in a high paced start-up environment, where a pragmatic, resourceful, well organized and effective approach is required with limited resources;
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A hands-on approach and a proven ability to work independently and as a team player
with excellent communication skills;
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Highly adaptable to novel work environment;
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Ability to work in a multidisciplinary and international environment.
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