Clinical Trial Manager

Employer
STALICLA SA
Location
NY, New Jersey, Massachusetts, East Coast (Remote)
Posted
Apr 06, 2021
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:

  • Develop and manage comprehensive study timelines and metrics (incl. budget development, timelines, milestones definition);

  • Develop and manage study budget with financial goals;

  • Prepare and present project debriefings, as required, plan, execute and lead or participate

    in study specific meetings; Vendor Management:

  • Identify and assist in selection of external vendors as required and in the development of vendor specifications;

  • Track & manage study contracts to provide timely and accurate forecast;

  • Ensure adequate study-specific training to clinical research staff;

  • Lead and coordinate study-related vendors and serve as primary point of contact for

    contracted CROs, study staff and contract labs;

  • Identify potential risks and resolve issues with CROs while establishing vendor

    management plans and reviewing quality metrics; Clinical site selection and management:

  • Participate in site selection;

  • Develop relationship with PI and site staff;

  • Participate in the preparation of contracts;

  • Prepare or participate in review site documents, including site specific informed consent

    form, study tools/worksheets;

  • 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:

  • Design clinical trials protocols with Clinical team and consistent with clinical development plan;

  • Prepare, or provide input on, study related documentation including CRFs, ICF template, monitoring templates, protocol worksheets, procedural manuals;

  • Prepare and/or review study related documents, including monitoring plan, patient diary, clinical site procedures manual, pharmacy/laboratory manuals, CRF completion guidelines;

  • Provide input and support documentation for AEs safety monitoring while collaborating with Clinical Team for regulatory authorities report submissions;

  • Coordinate with CMC, clinical supply study drug manufacture, packaging, labeling, and distribution

  • Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts;

  • Review proposed study protocols to evaluate factors such as sample collection processes, data management plans;

  • Communicating with laboratories or investigators regarding laboratory findings;

  • Ensure trial execution as per international GCP guidelines, local regulations and SOPs;

  • Participate in planning of QA activities, coordinate and ensure resolution of audit

    findings;

  • Ensure audit-ready clinical trial documentation including study-related files;

  • Lead cross-functional study Team (internal and external) including CROs, vendors,

    Clinical sites, Regulatory Affairs.

Requirements:

  • C2 level or native English mandatory;

  • Confirmed experience in Pharma/CRO industry with at least 6 years’ background in

    Clinical Project Management, including prior experience managing contracted

    resources/CRO;

  • In depth know-how and strong experience in site monitoring and clinical data review;

  • Excellent knowledge of clinical trial design and development;

  • Good understanding/previous experience in regulatory affairs, documentation to FDA

    (incl. IND);

  • In depth knowledge of ICH-GCP, local legislation and procedures;

  • Experience in management of study budget and contracts;

  • Experience in risk assessment, development of mitigation plans and continuous review

    and adjust plans as required;

  • Highly motivated by clinical research in Neurodevelopmental Disorders – Results

    oriented;

  • Clinical research or pharmaceutical experience in CNS disorder, with in depth

    understanding of early to late-phase clinical development programs;

  • Training in Psychology or Neuropsychology with working knowledge of

    neurodevelopmental disorder patients’ population preferred;

  • Experience in pediatric programs is a plus;

  • Excellent communication both orally and written;

  • Respectful of deadlines;

  • Proficiency in all of Microsoft Office;

  • Hard working, driven to achieve creative and sound results.

  • Good negotiation and communication skills;

  • High performer with capacity to work autonomously;

  • Flexibility to travel.

In addition, the candidates are expected to have:

  • 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;

  • A hands-on approach and a proven ability to work independently and as a team player

    with excellent communication skills;

  • Highly adaptable to novel work environment;

  • Ability to work in a multidisciplinary and international environment.