Clinical Operations Lead

Job title : Clinical Operations Lead
Location :
Job type : Permanent
Contact name : Crystal Leung
Contact number : +44 (0) 207 255 6600
Contact email : crystal.leung@seclifesciences.com

SEC Life Sciences is partnering on an exciting global role for a neurodegenerative-focused pharmaceutical company. This is a permanent, full-time position offered homebased. My client is seeking an energetic and business-savvy Clinical Operations Lead with 6 years of relevant experience. The role will report to the Head of Clinical Operations in the US and be responsible for overseeing all aspects of clinical trial activities on assigned studies in EUMEA.

The ideal candidate will possess a relentless drive, be able to forge meaningful relationships, and pursue their day with audacious curiosity. Having the skills to manage outside vendors and develop relationships between the Sponsor and site personnel is essential.

Offering a competitive salary package based on experience, the company offers a great work life balance with uncapped holidays!

Job Responsibilities:
*Manage activities of vendors and investigators to ensure compliance with the study protocol and overall clinical objectives.
*Plan and implement clinical research studies within budget and on schedule
*Coordinate and lead study team meetings and update the Clinical Team on timelines and milestones for the study.
*Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, and designing CRFs.
*Participate in study site selection; review and update site-specific consent forms; track patient accrual and study progress via standard reports; assure patient eligibility; document protocol deviations/violations; and manage adverse event reporting.
*Oversee clinical monitoring from site qualification to site closure visits and assure the integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records. Evaluate and analyze clinical data.
*Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
*Review and negotiate contracts & budgets.
*Ensure that study documentation is maintained according to applicable regulations, industry-accepted standards, and SOPs that govern clinical studies both in the field and in-house.
*Develop SOPs, work instructions, and standardized forms to define Clinical Operations processes within a small but growing team.
*Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and company SOPs.

Required Skills & Qualifications:
*B.S. and/or M.S. degree in a scientific discipline and at least six (6) years of clinical research experience; exposure to EUMEA region is required.
*Experience in rare disease, orphan or neurology is highly desirable.
*Demonstrates advanced knowledge of and appropriate experience of relevant software packages (e.g. Microsoft Project, Word, Excel) and the company's systems and programs.
*Must have strong oral and written communication skills with monitoring, study management, and SOP-development experience.
*Must be highly adaptable, proactive, deadline- and detail-oriented, and will maintain a high level of professional expertise through recent industry training and familiarity with clinical research publications.
*Quality (GCP) and/or Data Management experience is a plus.
*Ability to work independently under general direction in a fast-paced environment.
*Fluent in English; any additional European languages a plus.
*A keen eye for detail; crosses your T's and dots your I's
*Quality (GCP) and/or Data Management experience is a plus
*Experienced in Phases I-IV


Offered homebased anywhere in the EU or UK, with occasional travel to HQ in the US and the Netherlands.

If this position sound exciting to you, please send your CV to Crystal at crystal.leung@seclifesciences.com briefly outlining your study/project management experience and suitability for the role. For further information call +44 207 255 66 20.