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).

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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

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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

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