at Merck in Springfield, Illinois, United States
Job Description
Job Description
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.
Responsibilities include, but are not limited to:
+ Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
+ Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
+ Gains an in-depth understanding of the study protocol and related procedures.
+ Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
+ Participates & provides inputs on site selection and validation activities.
+ Performs remote and on-site monitoring & oversight activities using various tools to ensure:
+ Data generated at site are complete, accurate and unbiased.
+ Subjects’ right, safety and well-being are protected.
+ Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
+ Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
+ Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
+ Identifies, assesses and resolves site performance, quality or compliance problems and
+ escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
+ Works in partnership with GCTO country operations, finance, regulatory affairs,
+ pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
+ Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
+ Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
+ Supports and/or leads audit/inspection activities as needed.
+ Performs co-monitoring visits where appropriate.
+ Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
Extent of Travel:
+ Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week. Current driver’s license preferred.
+ Must reside in Southeast Region (GA, NC, SC, TN, FL, AL, MS) of the US to fulfill local travel within the region
Qualifications, Skills & Experience
CORE Competency Expectations:
+ Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
+ Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
+ Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
+ Hands on knowledge of Good Documentation Practices.
+ Proven Skills in Site Management including management of site performance and patient recruitment.
+ Demonstrated high level of monitoring skill with independent professional judgment.
+ Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
+ Ability to understand and analyse data/metrics and act appropriately.
+ Capable of managing complex issues, works in a solution-oriented manner.
+ Performs root cause analysis and implements preventative and corrective action.
Behavioural Competency Expectations:
+ Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
+ Demonstrated high level of monitoring skill with independent professional judgement.
+ Able to work highly independently across multiple protocols, sites and therapy areas.
+ High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
+ Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
+ Demonstrates commitment to Customer focus.
+ Works with high quality and compliance mind-set.
+ Positive mindset, growth mindset, capable of working independently and being self-driven.
+ Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.
Experience Requirements:
Required:
+ Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.
Educational Requirements:
Preferred:
+ B.A./B.S. with strong emphasis in science and/or biology
MRLGCTO
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We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by appl
