Job Description
This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our Company policies and procedures and with quality standards internally and externally.
Under the oversight of the CRD / Director, Clinical Research, the individual is responsible to manage/oversee a team of CTCs.
As line manager the role is critical to continuously develop future talent by providing training, support and mentoring to the CTCs, as well as for interns delegated to the Clinical Operations team based on the Internship program, while properly managing situations of low or non-performance.
The role will work across the different country operations roles (e.g. CRM, CRA-Manager, Partners, TA-Head, CRD and Sr.COM) to ensure alignment and development of the country CTC capabilities. The person contributes to CTC capacity/resource planning activities to ensure efficient allocation of resources and work.
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Responsibilities include, but are not limited to:
- Has significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up
- Ensure and oversee proper on-boarding and off-boarding of employees, compliance to initial and ongoing trainings.
- Train and oversee the CORE competencies, ICH-GCP knowledge, Clinical Research environment 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, GTT compliance, expense reports, time-off 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, TA-Heads, CRMs, CRA-Manager, Sr. COM, CRAs, Partners 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 CRA.
- Interface with GCTO partners on clinical trial execution as assigned; including acts as lead liaison with CTC FSP partners in facilitating coordinated process and country delivery.
- Escalates site performance issues to CRM and CRD/TA-Head.
- People and Resource Management:
- Manages CTC - career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.
- Supports and resolves escalation of issues from CTCs.
- Manages capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.
- Ensures CTC compliance to corporate policies, procedures and quality standards.
Skills:
- Demonstrates proactive leadership and must be able to in/directly influence vendors, external partners and country managers to deliver these commitments within specified timelines with minimal oversight from the line manager.
- Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding of the pros and cons of each decision and takes ownership of decisions.
- 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 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.
- Strong coordination and organizational skills.
- 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 internal stakeholders and external partners
- Fluency in both English and local language
Qualification & Experience:
- Minimum of 5 years experience within Clinical Research, preferred experience in the role of CTC, CRA or similar role.
- Line management experience preferred or at the minimum team leader experience.
EducationalRequirements:
Required:
- Bachelor's Degree (or comparable) in Business Administration/ Life Science
Preferred:
- Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or Clinical Research Management/Administration.
ResearchandDevelopmentDivisionGCTO
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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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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:
25%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
10/21/2024
*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.
Requisition ID:R318031