**Job Description**
This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and 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 Managers (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%
**Qualifications, Skills & Experience**
**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
**Experience Requirements:**
+ 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
**Educational Requirements:**
+ Bachelor’s degree in science
\#eligibleforERP
ResearchandDevelopmentGCTO
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, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range:
$139,600.00 - $219,700.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
**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:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
50%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
NA
**Job Posting End Date:**
03/31/2025
***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.**
**Requisition ID:** R341453
