***This position can be worked remotely in Europe***
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.
A Clinical Trial Lead (CTL) is a member of the project team responsible for the execution of the clinical trial(s) at the site level, accountable for development and execution of the Monitoring Plan (MP), site identification and selection, CRA and site training, development of CRA and site materials, trackers, and logs necessary to track and document deliverables. The CTL will review monitoring visit reports and track actual to projected variables and parameters related to CRA & site activities. All activities will be in compliance with cGCPs, country specific regulations, ICH Guidelines, and SOPs.
Responsibilities: Develop comprehensive Monitoring Plans (MP) inclusive of but not limited to:Monitoring standards (During start-up, enrollment & study close)Communication planSelection, qualification & training of monitorsMonitoring methods (including monitor and site training)Investigator Site File oversightInvestigational product managementSource data verification processesProtocol deviation tracking & resolution Plan and manage study startup including site identification, qualification, selection and initiation activities Lead Clinical Monitoring activities through site activation, maintenance and study closure Develop study specific templates for use by the Clinical Monitoring team (CRAs) and/or sites Establish clinical monitoring study milestones and ensure accurate tracking and reporting of study metrics Provide study-specific guidance, training, and support for the Clinical Monitoring team Prepare weekly status reports and agendas Effectively interact and communicate with clients on a daily basis Lead internal and external client meetings Ensure that clinical trials are conducted in accordance with country’s regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures Conduct monitoring visits as needed May review monitoring visit reports and track report metrics to ensure compliance Provide input to clinical trial budgets and staffing/resourcing plans Participate in clinical operations initiatives and programs as assigned Prepare and attend bid-defense meetings, kick off meetings, investigator meetings and other study-specific meetings as required Conduct Quality Assessment visits for CRAs Other duties as assigned
Qualifications: Education: Minimum requirement of a Bachelor’s degree in biological sciences, healthcare, pharmacy, or nursing; MS/MSc. or PhD preferred
Training / Demonstrate Understanding The list below includes the general training subjects, and not necessarily the exact name of the training course obtained: Applicable Standard Operating Procedures Good Clinical Practices (ICH Guidelines; Good Quality Practices) and local country regulations (as needed) 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidances; Computerized Systems Used In Clinical Trials) Good Clinical Data Management Practices HIPAA – Protected Health Information/GDPR-General Data Protection Regulation, as applicable Drug Development and Regulatory Approval Processes (depending on applicable territory(ies) Strong computer acumen in technology applications, including but not limited to, use of eTMF, EDC, CTMS, site EMR systems, etc.
Certification Member of ACRP/ICR/SoCRA preferred
Experience: 5+ years clinical research experience 2+ years CRA level experience (both CRO and industry experience are acceptable) Excellent verbal and written communication, and presentation skills Excellent interpersonal and organizational skills with attention to detail Strong computer proficiency in MS Office including Outlook, Word, Excel, and PowerPoint Strong critical thinking, problem solving and analytical skills Ability to efficiently organize and prioritize tasks within a multifaceted framework and set deadlines Excellent documentation skills Ability to maintain excellent working relationships with a broad range of trial staff Ability to work well in a team environment but also independently without significant oversight; Flexibility in work hours and ability to travel
Language Must be fluent in English and in the languages of the regions/territories that are assigned
Other Requirements Must possess a current passport, identity card, and valid driver’s license
Equal Employment Opportunity
It is Advanced Group’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.
This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.