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.