Lead Site Manager (Lead CRA - Monitor de Pesquisa Clínica Lead)

Principal Responsibilities:

• Acts as primary local company contact for assigned sites for specific trials.
• Actively participate and provide in-depth insights in site feasibility and/or Site Qualification Visit.
• Leads investigator meetings as needed. Presents study updates and facilitates discussions between meeting participants.
• Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. Able to implement and execute all tasks independently with great proficiency. Also expected to oversee, train, mentor more junior Site Manager and support functional manager with completion of junior site manager accompanied site visits (ASVs) as required.
• Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe. Expected to anticipate obstacles and proactively look for solutions and share practices with other sites to accelerate start up and mitigate against study issues.
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas. May be required to support LTM in drafting country level recruitment strategy and contingency planning.
• Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
• Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
• Arranges for the appropriate destruction of clinical supplies.
• Ensures site staff complete data entry and resolve queries within expected timelines.
• Ensures accuracy, validity and completeness of data collected at trial sites
• Ensures that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
• Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
• Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
• Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
• Leads collaboration with LTM for documenting and communicating site/study progress and issues to trial central team, proposing solutions and strategies for improvement and leads additional country insight gathering.
• Active participation in regularly scheduled team meetings and trainings. Provide feedback as appropriate. Expected to lead/provide leadership at these meetings.
• Complies with relevant training requirements. Act as local expert in assigned protocols. Possesses in-depth therapeutic knowledge sufficient to support role and responsibilities as well as other Site Managers within the same therapeutic area.
• Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. Compliance Monitoring Visit (CMV). May be required to oversee audit and inspection preparation by Associate SM.
• Prepares trial sites for close out, conduct final close out visit.
• Tracks costs at site level and ensure payments are made, if applicable. May be required to support LTM in tracking costs across sites at the country level.
• Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. May be required to prepare communications to all sites within the country. May be required to function as Site Engagement Lead across studies at a site.
• May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
• Acts as a point of contact in site management practices. Able to provide authoritative insights, expert advice and share best practices
• Will routinely be assigned as a coach and mentor to a less experienced site manager.
• Expected to contribute to process improvement and training.
• Routinely requires to leads and/or participates in special initiatives as assigned.
• Will routinely be expected to assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”

Education and Experience Requirements:

• A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field (or equivalent experience) is required.
• A minimum of 6 years of clinical trial monitoring experience is required. 8-10 years of clinical trial monitoring experienced is preferred; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
• Experience in mentoring/coaching and providing training to others SM. Strong leadership skills, ability to lead initiatives, to act as a lead SM.
• Specific therapeutic area experience, knowledge or expertise is expected and required. Significant years of experience in key therapeutic areas will be an added advantage.
• Expert knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and company systems.
• Willingness to travel with occasional/regular overnight stay away from home depending on the region.
• Proficient in speaking and writing the country language and English. Good written and oral communication skills.
• Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment.
• Ability to work on multiple trials in parallel in different disease areas.
• Demonstrated capability to consistently deliver clinical trials of high complexity or high degree of difficulty. Able to anticipate obstacles and proposed solutions to manage them effectively.
• Demonstrated strong site engagement/site relationship capability especially with identified key/strategic sites.
• Demonstrated problem solving capability and ability to manage stressful situations.
• High degree of competency, interest and aspiration to be a career Site Manager

Required Skills:

Preferred Skills:

Clinical Data Management, Clinical Evaluations, Clinical Research and Regulations, Clinical Trial Protocols, Clinical Trials Operations, Communication, Data Savvy, Empowering People, Issue Escalation, Laboratory Operations, Problem Solving, Program Management, Project Support, Research and Development, Standard Operating Procedure (SOP), Study Management, Technical Credibility