Job Description
Our Clinical Research and Pharmacovigilance team pushes 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.
Under the oversight of the Clinical Research Director (CRD), this position will manage a team of Emerging Talent CTCs (ET-CTC)and/or Emerging Talent Rotation Associates (ETRAs). This position will also work to ensure excellent study administrative performance with strict adherence to local regulations, company Standard Operating Procedures (SOPs) and International Conference on Harmonization Good Clinical Practice (ICH GCP).
As line manager, the role is critical to continuously develop future talent by providing training and mentoring to the CTCs, as well as overseeing the Intern to Hire and Summer Intern candidate program while properly managing situations of low or non-performance. The role will work at the country level with other local stakeholders e.g. Clinical Research Manager (CRM) and CRD to ensure alignment and development of the country’s CTC capabilities. The role will engage with country Partner Line Manager (PLMs) and CRMs to ensure alignment across all monitoring therapeutic areas. The person contributes to CTC capacity/resource planning activities to ensure the efficient allocation of resources and work.
Primary duties include, but are not limited to:
Ensure and oversee proper on‐boarding and off‐boarding of employees, compliance with initial and ongoing training.
Train and oversee the core competencies, ICH‐GCP knowledge, clinical research environment, monitoring etc.
Assure adherence to GCP guidelines, processes, and procedures related to direct reports’ activities and performance.
Ensure direct reports are compliant to the timelines and key business metrics.
Review and approve timesheets, Global Time Tracking compliance, expense reports, timeoff requests and provide proper oversight of CTC’s productivity/utilization.
Provide input for capacity planning, including reporting of current manpower and forecasting of CTC capacity and needs, to provide efficient use of resources.
Work with CRDs, CRMs, CRAs, PLMs, and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.
Interacts with CRMs and sites as needed to resolve operational issues, to meet commitments in a timely manner and in coordination with the study CRM and Clinical Research Associate (CRA).
Interface with Global Clinical Trial Operations (GCTO) partners on clinical trial execution as assigned; acts as liaison with CTC Functional Service Providers partners in facilitating the coordinated process and product delivery.
Escalates site performance issues to CRM and Clinical Research Director (CRD).
People and Resource Management
Support and manage CTC – career development, performance reviews, etc., including addressing low-performance situations, and taking appropriate actions.
Manage and resolve escalation of issues from CTCs.
Contribute to Headquarter capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resources and work.
Ensures CTC compliance to corporate policies, procedures, and quality standards
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 and leadership
Skills and judgment 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 the ability to work within these guidelines
Expertise in and excellent working knowledge of core trial management sy tems 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 needed:
Minimum of 5 years within Clinical Research
Minimum of 3 years as CRA monitoring clinical trials
Background in line management or team lead preferred
Educational Qualifications:
Required:
BA/BS degree with emphasis in science and/or biology
Preferred:
#eligibleforerp
ResearchandDevelopmentGCTO
Current Employees apply HERE
Current Contingent Workers apply HERE
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 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:
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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.
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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:
$135,500.00 - $213,400.00
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.
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:
10%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
11/24/2024
*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.
