Senior Clinical Trial Associate - Biotechnology

Posted 08 January 2024
Salary Negotiable
Job type Full Time
Discipline CRO & Clinical Operations
Contact NameChristian Lee

Job description

Mantell Associates is partnered with an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. As a result of continuous progress in their projects, they are searching for a highly motivated and experienced Senior Clinical Trial Associate (CTA) to join their dynamic team.

As Senior CTA, you will play a crucial role in supporting the Clinical Trial Manager (CTM) and any other team members, as necessary, in the day-to-day clinical operations activities for the planning, execution, and management of assigned clinical trial(s).

Senior Clinical Trial Associate - Responsibilities:

  • Clinical Operations Support:

  • Provide administrative support for designated clinical research personnel including CTMs in accordance with applicable local laws, international guidelines, and SOPs

  • Provide overall support to the clinical team from study startup to closure: e.g., prepare meeting agenda, summarize meeting minutes, support in preparing presentations, regular status reports etc.

  • Collaborate with the CTM to ensure the smooth execution of clinical trials

  • Assists the CPM with Sponsor oversight, study specific documentation review and QC including review of informed consent form, study plans, study reference manuals, eCRF, etc.

  • Assist with creation and maintenance of study metrics trackers, tools and reports

  • Assist the clinical team in interacting with CROs, vendors and collaborators

  • Contribute to streamlining processes in assigned studies

  • Assist in coordination and tracking of Investigator and third-party payments

  • Support the review and tracking of invoices from vendors/consultants

  • Documentation and Record Keeping:

  • Maintain and organize trial documentation, ensuring compliance with regulatory standards, company SOPs and ensuring all documentation is in a state of audit readiness

  • Responsible for up to date filing in the in-house part of the trial master file (TMF)

  • Perform TMF QC activities per SOP and oversee coordination of issue remediation where needed

  • Assist the CPM with Sponsor oversight of CRO-held eTMFs periodic audit and findings resolution

  • Preparation and review of essential trial documents, as necessary

  • Contribute to the review and QC of clinical core documents (e.g., Investigator Brochure, trial protocol, trial amendments, patient information sheet and consent form)

  • Support the preparation, conduct and follow-up of GCP audits and GCP inspections

  • Assist with archiving study documents for completed clinical trials

  • Site Management:

  • Liaise with investigational sites, as necessary, to facilitate the timely initiation and conduct of trials

  • May contact clinical sites/CRO for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc.. when requested)

  • Assist in the tracking and resolution of site-related issues

  • Assist the CPM and clinical team with Investigator Meeting coordination, activities preparation and generate meeting minutes

  • Assist in quality assessment visits, if applicable

  • Protocol Compliance:

  • Assist in ensuring adherence to study protocols, regulatory requirements, and SOPs

  • Assist in the development and implementation of training materials for site/CRO personnel

  • Cross-Functional Collaboration:

  • Work closely with cross-functional teams, including regulatory, data management and quality assurance, to achieve project milestones

  • Participate in internal and external meetings as a representative of the clinical operations team and generate meeting agenda and minutes as needed

Senior Clinical Trial Associate - Requirements:

  • 3-5 years' experience as a CTA or experience in a similar role (e.g., Project Specialist, Clinical Study Coordinator) preferably on the Sponsor/pharma side

  • Knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical trials

  • Experience and knowledge of eTMF management, CTMS preferable

  • Proficient in standard software (Word, Excel, Outlook, Power Point); CTMS/EDC systems

  • Display excellent organisation and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities

  • Good interpersonal skills and ability to work in a team environment with a collaborative approach

  • Proficient in English (written and spoken)

  • Strong verbal and written communication skills

  • Residency in Berlin or other German city with the ability to relocate on short notice, or travel to Berlin regularly

  • Scientific or healthcare field educational background, preferred

  • Experience in oncology, immune oncology is a plus

  • Experience in large phase II or phase III studies is an asset

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.