Clinical Research Associate - Scotland
Location
United Kingdom
Posted
89 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Clinical Research Associate - Scotland
MSD
Job Description Clinical Research Associate Location: Scotland Travel: Approximately 65–75% (about 2–3 days per week, domestic and international) About our company Our company is committed to advancing high-quality clinical research that upholds ICH/GCP standards and local regulatory requirements. We collaborate across global and regional teams to deliver studies with excellence, integrity, and patient safety at the core. Role overview We are seeking a highly skilled Clinical Research Associate (CRA) to lead performance and compliance for assigned protocols and sites within the South East. Under the oversight of the CRA Manager or Clinical Research Director (CRD), you will serve as the primary site contact throughout all phases of clinical studies, ensuring rigorous adherence to ICH/GCP, local regulations, our company policies and procedures, quality standards, and adverse event reporting requirements. You will take ownership of allocated sites, actively expand our clinical research territory by identifying and developing new sites and contribute as a subject matter expert on monitoring processes and systems across internal workstreams. Key responsibilities - Build and sustain strong relationships with investigative sites across all trial phases. - Perform site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws/regulations, protocol, site monitoring plans, and related documents. - Develop deep understanding of study protocols and procedures. - Coordinate cross-functional tasks to achieve Site Ready status. - Participate in site selection and validation; provide informed input to decisions. - Conduct remote and on-site monitoring to ensure: - Data integrity (complete, accurate, unbiased). - Protection of subjects’ rights, safety, and well-being. - Execute validation, initiation, monitoring, and close-out visits; document clear, comprehensive visit and non-visit reports in a timely manner. - Collect, review, and monitor regulatory documentation for start-up, maintenance, and close-out. - Communicate proactively with investigators and site staff on protocol conduct, recruitment/retention, deviations, regulatory findings, audits/inspections, and site performance. - Identify, assess, and resolve site performance, quality, or compliance issues; escalate appropriately per the CRA escalation pathway in collaboration with CRA Manager, CRM, TA Head, and CRD. - Partner with internal teams (country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ) and external stakeholders (vendors, IRB/IEC, regulatory authorities). - Maintain accurate, timely documentation in CTMS, eTMF, and other systems. - Act as a process SME: share best practices, drive continuous improvement, and deliver training. - Support and/or lead audit/inspection activities. - Contribute to country strategy by identifying and onboarding potential new sites; build site capabilities. - Mentor and buddy junior CRAs; conduct co-monitoring and quality control visits where appropriate. Travel requirements - Ability to travel domestically and internationally approximately 65–75% of working time (about 2–3 days per week). - Valid driver’s license preferred; required in certain countries. Qualifications, skills, and experience Core competencies - Fluent in English, with strong written and verbal communication skills and the ability to present technical information effectively. - Robust knowledge of clinical research, trial phases, ICH/GCP, and local clinical research regulations and guidelines; ability to work within global, country, and regional frameworks. - Demonstrated mentoring and leadership capability. - Hands-on knowledge of Good Documentation Practices. - Proven site management expertise, including independent oversight of site performance and patient recruitment. - High-level monitoring skills with sound, independent professional judgment. - Strong IT proficiency (MS Office and clinical applications across computer, tablet, and mobile); adaptable to new tools. - Ability to interpret data/metrics and take appropriate action, including in virtual settings. - Experience conducting site motivation visits to boost enrollment. - Solution-oriented approach to complex issues; capable of root cause analysis and implementing preventive/corrective actions. - Ability to mentor junior CRAs and perform co-monitoring visits. Behavioral competencies - Excellent time management, organization, interpersonal skills, conflict management, and problem solving. - High independence across multiple protocols, sites, and therapy areas. - Strong sense of accountability and urgency; able to prioritize and multitask in changing environments. - Effective in a matrixed, multicultural setting; fosters culturally sensitive relationships. - Customer-focused mindset with high standards of quality and compliance. - Positive, growth-oriented, self-driven, and professional demeanor aligned with company values. Education and experience - Bachelor’s degree (or higher) with extensive direct site management (monitoring) in bio/pharma/CRO. What we offer - Opportunity to shape clinical research at high-performing sites and contribute to global development programs. - A collaborative environment with growth, mentorship, and continuous improvement. - Competitive compensation and benefits. How to apply Please submit your resume/CV and a brief cover letter outlining your relevant monitoring experience and site leadership achievements Required Skills: Accountability, Adaptability, Adverse Event Reporting System, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trials Monitoring, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Protocol Adherence Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Remote Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 05/5/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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Regional Clinical Trial Management Associate
BeiGeneBeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: - Supports the Regional Clinical Study Manager in regional study delivery and ensures that delegated components of clinical studies are executed per expected and specified quality standards, within timelines and budget - Builds solid knowledge of clinical trials operations in the region under guidance of the Regional Clinical Study Manager - Supports the alignment of regional deliverables with overall study goals under the direction of the Regional Clinical Study Manager Essential Functions of the job: Regional Trial Support & Collaboration - Develops regional study management experience by supporting to oversee multiple aspects of clinical trial conduct including feasibility assessment, study start-up, document generation and review, tracking of samples and enrollment of study participants. - Acquires solid knowledge of clinical research operations, including interpretation and implementation of regulations/ICH guidelines - Supports the Regional Clinical Study Manager with set up and logistics of regional team meetings (agenda, minutes, ..) - Establishes good collaboration with Regional Clinical Study Manager, the Global Study Management Associate and other key stakeholders regionally and globally - As required, supports CRAs with various activities such as monitoring visit preparations, TMF filing, .. Timelines, Planning and Execution - Creates and maintains regional/country level SharePoint folders for the study and regional study team distribution lists - Sets up the countries and sites in the region in the appropriate systems e.g. eTMF, CTMS, ..and makes sure information is kept up to date - Supports system access requests for the region/country and ensure these are managed appropriately across the study life cycle, supports user account management for users in region - Might support the local adaptation of global documents under supervision of the Regional Clinical Study Manager - May assist in the review of study-related documents as they relate to the supported clinical trials as delegated by the Regional Clinical Study Manager (e.g., Informed consent forms, regional Pharmacy Manual, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines and other relevant regional study plans and charters) - Supports study start up in region/country in close collaboration with the regional study start up team and the Regional Clinical Study Manager - Supports the organization of study specific investigator meetings together with the Regional Clinical Study Manager and the Global Study Management Associate - Supports the TMF specialist with country/site level TMF creation and maintains the country/site level TMF including regular review and QC of TMF documents as per the study TMF QC plan - Helps resolving any regional/country specific issues related to clinical supplies in collaboration with relevant stakeholdersd - Supports the data cleaning activities and contributes to the follow up of outstanding information for region/country - Prepares site newsletters and other correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study team - Might assist in resolution of routine study questions from clinical trial sites - Might support the maintenance of information for region/country in relevant public registries (e.g CT.gov) - Supports the Regional Clinical Study Manager with providing all relevant information from region/country to be included in the Clinical Study Report Quality - Supports the identification of operational risks and works with the Regional Clinical Study Manager to recommend solutions for discussion with appropriate team leadership - Learns and shares best practices in clinical operations methodologies, systems and processes with the emphasis on quality and compliance - Might support the preparation of sites for quality assurance audits and inspections - Suggests improvements to enhance the efficiency and the quality of the work performed on assigned projects - Might support the development of local/regional tools, working instructions and SOPs Budget - Supports set up of vendors for activities outsourced in region/country - Supports management of regional study budget incl PO set up - Supports PO set up for regional vendors Education Required: - Bachelor’s Degree in a scientific or healthcare discipline required*, Higher Degree preferred *exceptions might be made for candidates with relevant clinical operations experience Computer Skills: MS Office Other Qualifications: - Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes - 1 or more years of experience in clinical research within biotech, pharma or CRO industry Travel: Limited travel might be require Salary Range UK: 36,200.00 GBP - 45,200.00 GBP Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. - Fosters Teamwork - Provides and Solicits Honest and Actionable Feedback - Self-Awareness - Acts Inclusively - Demonstrates Initiative - Entrepreneurial Mindset - Continuous Learning - Embraces Change - Results-Oriented - Analytical Thinking/Data Analysis - Financial Excellence - Communicates with Clarity We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
• Accountable for regional study delivery with appropriate inspection readiness quality • Leads the regional clinical operations team and acts as point of escalation for resolution of issues • Ensures alignment of regional deliverables with overall study goals • Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities • Ensures timely availability of local adaptations of global study documents • Manages the trial data collection process for the region, drives data entry and query resolution


