Job Information
Merck Clinical Research Director (CRD) - General Medicine (REMOTE) in Montgomery, Alabama
Job Description
The Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for GCTO country operations.
Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is accountable for trial quality and audit responses and completion of CAPAs. The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases in scope of GCTO within the country/cluster.
The position has multiple touch points across the company which will be dependent on country/cluster and the study type and stage.
CRD is the primary country/ cluster level contact for GCTO and has the following key responsibilities:
Supports the regional GCTO leadership team, leading strategic development of their country / cluster to deliver clinical trials as per global clinical research pipeline requirement.
Strategic country / cluster representative for initiatives at all levels of the organization.
Build and lead the team to effectively manage resources ensuring appropriately skilled and high performing team to effectively deliver the portfolio across therapy areas and achieve on agreed GCTO, GCD, and ourResearch & Development Division objectives.
Leads strategic development and management of institutional & investigator relationships in conjunction with our Research & Development Division / GCD Therapy Areas, and when appropriate Human Health.
Working with regional and global colleagues develops and executes the GCTO strategy for the country/cluster - such as Industry associations.
Leadership and Management of the GCTO country / cluster Organization:
Recruits and hires talent.
Proactively manages and develops talent.
Proactively identifies new opportunities and gaps to support emerging needs and addresses by reallocating and training of existing staff and/or external recruitment.
Creates an empowering, compliant, collaborative, and innovation-focused work environment.
Builds a culture of quality and compliance through training, oversight, and collaboration.
Oversight to ensure appropriate scientific and operational training for staff members.
Clinical Operation Management:
- Ensures a single point of contact for managing clinical trial execution in all its aspects across all studies & phases in scope of GCTO within the country/cluster.
Leadership and oversight of the following:
Our Research & Development Division / GCD / GCTO goals, initiatives and expectations.
Development and delivery of company standards in given geography.
Activities of all cluster/country level GCTO team & all programs and studies.
Approved administrative budget to support GCTO team (e.g., salaries & travel).
Country level operational study budgets.
Regulatory Inspections and internal audits; responding to inquiries by health authorities, ethics committees, and internal auditors in conjunction with CCQM, compliance, Regulatory, Pharmacovigilance (PV) and Medical Affairs.
Responsible and supports development of audit responses and completion of CAPAs.
Collaborates and supports:
Functional Service Provider (FSP) Senior, Regional and local Leadership to ensure adequate and appropriate resourcing for company internal clinical trial portfolio.
Clinical Research Organization (CRO) Senior, Regional and local Leadership to ensure the successful conduct of outsourced clinical trials.
Engagement With Key External Stakeholders
Supporting Management and the clinical operations of studies managed by GCTO.
Support the development and management of Investigator and operational relationships in conjunction with all ourResearch & Development Division Therapy Areas, and when appropriate Human Health colleagues.
Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with Key Opinion Leaders (KOLs), etc.).
Quality / Compliance Adherence / Standard:
Ensure that compliance, quality and timeline objectives are met for all trials executed in the country.
Sets clear performance standards and holds self and organization accountable for achieving results. Embraces GCTO metrics and performance standards (KPI’s).
Work collaboratively in a matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs) and Regional Operations Teams, to deliver objectives.
Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group and the Good Clinical Practice Quality and Compliance Council (GCP QCC).
Extent of Travel : up to 30%
CORE Competency Expectations:
Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders within GCTO and our Research & Development Division in a matrix organization.
Management expertise should cover management of budget, travel, resources, headcount, processes (and controls), productivity, quality and project delivery.
A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.
Strong Communication skills requiring proficiency in written and spoken English and preferably local language. The incumbent must be competent and effective in written and verbal communication.
Strategic thinking.
Behavioral Competency Expectations:
High emotional intelligence.
Strong leadership that will attract, motivate, inspire, develop and retain talented staff. In addition, Leadership skills that enable and drive alignment with the goals, purpose and mission of our Company's Research Labs, Global Clinical Development (GCD) and GCTO
Positive proven success in people management.
Educational Requirements:
Required :
- Bachelor’s degree in science or equivalent healthcare experience
Preferred :
Advanced degree, (e.g., MD, PhD, Pharm D, MS, MBA)
Small-sized country / low to mid-complexity geography*
5 years or more Experience in Clinical Trials**
3 years of more people management experience
*Criteria for complexity includes:
Country/affiliate size
Team size
Product portfolio
Pipeline and clinical trials
Scientific research environment, number of local data generations, Our Company Investigator Studies Programs
Access and healthcare policy environment
** Experience in Clinical Trial Operations gained from working at hospitals and/or research institutions, recognized clinical trial suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
ResearchandDevelopmentGCTO
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
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US and Puerto Rico Residents Only:
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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:
$164,800.00 - $259,400.00
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 (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
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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:
12/21/2024
*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: R326034