Clinical Research Manager - General Medicine (Remote)

5+ years

$135,500.00 - $213,400.00

Rahway

15 June 12, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Posting: Clinical Research Manager (CRM) - General Medicine (REMOTE)

Job Code: MERCUSR298758ENUS
Employer: Merck & Co.
Category: Clinical Research
Job Type: Full Time

Location

Country: United States
State: New Jersey (NJ)
City: Rahway
Post Date: 06/08/2024

Description

Position Description

The Clinical Research Manager (CRM) is primarily accountable for the end-to-end performance and project management of assigned protocols in a country, ensuring compliance with International Conference on Harmonization Good Clinical Practice (ICH/GCP), country regulations, company policies and procedures, quality standards, and adverse event reporting requirements. The CRM may be responsible for studies in several countries within a cluster.

Responsibilities

Serve as the main point of contact (POC) for assigned protocols and link between Country Operations and the clinical trial team (CTT).
Manage project planning and execution, driving and tracking performance to meet country commitments from feasibility, site selection, recruitment, execution, and close out.
Ensure protocol compliance with ICH/GCP, country regulations, company policies, and procedures.
Review Monitoring Visit Reports and escalate performance issues and training needs.
Perform Quality Control visits as required.
Lead local study teams, train local roles in the protocol, and support Clinical Research Associates (CRAs) as protocol experts.
Create and execute local risk management plans for assigned studies.
Ensure compliance with key systems (CTMS, eTMF).
Escalate challenges and issues to the appropriate levels within the organization.
Identify and share best practices across clinical trials and countries.
Collaborate with functional outsourcing vendors, investigators, and other external partners.
Act as a country POC for programmatically outsourced trials.
Build business relationships and represent the company with investigators.
Support local and regional strategy development in collaboration with CRD, TAH, and Regional Operations.
Collaborate internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs, and GHH.

Extent of Travel

Up to 30% of working time

Core Competency Expectations

Knowledge in Project Management and site management.
Strong organizational skills with demonstrated success.
Ability to make independent decisions and oversee clinical research activities.
Strong understanding of local regulatory environment.
Strong scientific and clinical research knowledge.
Understanding of clinical trial planning, management, and metrics.
Experience as a key link between Country Operations and Clinical Trial Teams.
Effective communication and collaboration in a remote/virtual environment.
Proficiency in written and spoken English and local language.
Strategic thinking.
Efficient remote and virtual work capabilities.
Understanding of cultural diversity.
Strong project management skills and/or certification.

Behavioral Competency Expectations

Strong leadership skills to align with company goals.
Ability to identify and resolve problems, conflicts, and opportunities early.
Skilled in negotiation and conflict resolution.
Ability to build and maintain professional relationships.

Position Qualifications

Education Minimum Requirement: Bachelor’s degree in Science (or comparable)
Preferred Education: Advanced degree (e.g., Master’s, MD, PhD)
Required Experience: Minimum 5 years in clinical research
Preferred Experience: CRA experience preferred

Additional Information

Travel Requirements: 25%
Flexible Work Arrangements: Remote
Valid Driving License: No
Hazardous Material(s): N/A
Job Posting End Date: 06/15/2024
Employee Status: Regular
Relocation: No relocation
Visa Sponsorship: No

Application Instructions

Current Employees: Apply HERE
Current Contingent Workers: Apply HERE

Equal Opportunity Employer

Merck & Co. is 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 U.S. Equal Opportunity Employment laws, visit:

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 their current position before applying for open positions.

If you have been offered a separation benefits package but have not yet reached your separation date, and you are offered a position within the salary and geographical parameters set forth in the Summary Plan Description (SPD) of your separation package, you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Vaccination Requirements

Employees working in roles requiring routine collaboration with external stakeholders, such as customer-facing commercial or research-based roles, must comply with Company and external stakeholders' policies regarding COVID-19 vaccination. If an essential function of your job is to meet with stakeholders who require vaccination, and you are not vaccinated, your employment may pose an undue burden to business operations.

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will work three total days on-site per week, generally Tuesday, Wednesday, and either Monday or Thursday. This does not apply to field-based, facility-based, manufacturing-based, or research-based positions or those covered by a collective-bargaining agreement unless specified otherwise.

Salary Range

Expected Salary Range: $135,500.00 - $213,400.00
Benefits: 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.

Search Firm Representatives

Merck & Co. does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at Merck & Co. without a valid written search agreement will be deemed the sole property of Merck & Co. No fee will be paid if a candidate is hired by Merck & Co. 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.

Apply to join a company that values bringing together diverse, talented, and committed people to drive breakthrough innovation in an inclusive environment. Respectfully challenge one another's thinking and approach problems collectively to create meaningful solutions.

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