at Merck in Springfield, Illinois, United States
Job Description
Job Description
Position Description:
This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director (CRD) or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 Clinical Research Associates (CRAs) and to ensure excellent study and site performance with strict adherence to local regulations, company Standard Operating Procedure (SOPs) and International Conference on Harmonization Good Clinical Practice (ICH GCP.)
As line manager, the role is critical to continuously develop key talents by providing training, support and mentoring to the CRAs and properly manage situation of low or non-performance.
The role will work at country level with other local stakeholder e.g. CRM to ensure alignment and development of the country capabilities. The role will collaborate with country Partner Line Manager’s (PLMs) to ensure alignment across all monitoring functions. The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.
Responsibilities include, but are not limited to:
+ Work allocation, staff development and performance appraisal.
+ Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.
+ Work with CRAs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.
+ Interacts with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner in coordination with the study CRM.
+ Attend local Investigator Meetings if requested to.
+ Interface with GCTO partners on clinical trial execution.
+ Escalates site performance issues to CRM and Clinical Research Director CRD.
+ People and Resource Management:
+ Manage CRA – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.
+ Support and resolve escalation of issues from CRAs.
+ Liaise with local HR and finance functions as required.
+ Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.
+ Provides training, support and mentoring to the CRA to ensure continuous development.
+ Ensures CRA compliance to corporate policies, procedures and quality standards
Extent of Travel: up to 50%
Core Competency Expectations:
+ Ability to work independently and in a team environment
+ Excellent people management, time management, project management and organizational skills
+ History of strong performance
+ Skills and judgment required to be a good steward/decision maker for the company
+ Fluent in Local Language and business proficient in English (verbal and written)
+ Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices and ability to work within these guidelines
+ Expertise in and excellent working knowledge of core trial management systems and tools
Behavioral Competency Expectations:
+ High emotional intelligence
+ Strong leadership skills with proven success in people management
+ Excellent interpersonal and communication skills, conflict management
+ Demonstrated ability to build relationships and to communicate effectively with external customers (e.g. sites and investigators)
+ Influencing skills
Position Qualifications:
Education Minimum Requirement:
+ Required: Bachelor’s degree in science
+ Preferred: Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology
Required Experience and Skills:
+ Minimum of 5 years´ experience within Clinical Research
+ Minimum of 3 years’ experience as CRA monitoring clinical trials
+ Line management experience preferred or at the minimum team leader experience
\#EligibleforERP
MRLGCTO
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.
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 applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\EEOC\KnowYourRights\10\20.pdf)
EEOC GINA Supplement?
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\%20English\formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific da