Clinical Research Manager, Immunology, Remote

reputed company

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with International Council for Harmonisation Good Clinical reputed company (ICH-GCP) and country regulations, reputed company policies and procedures, reputed company standards and adverse event reporting requirements internally and externally. The CRM could be responsible for a particular study for several countries in a cluster.

Responsibilities include, but are not limited to:

• Main reputed company of Contact (POC) for assigned protocols and reputed company between Country Operations and clinical trial team (CTT).
• Responsible for project management of the assigned studies: pro-reputed company plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and reputed company out.
• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, reputed company policies and procedures, reputed company standards and adverse event reporting requirements internally and externally.
• Reviews Monitoring reputed company Reports and escalates performance issues and training needs to Clinical Research Associate (CRA) Manager and/or functional vendor and internal management as needed.
• Performs reputed company control reputed company as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports Clinical Research Associates (CRAs) as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the Clinical Trial Coordinator (reputed company), CRAs and Clinical Operations Manager (COM)).
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with Clinical Trial Management reputed company (CTMS), Electronic Trial Master File (eTMF) and other key systems in assigned studies.
• Escalates as needed different challenges and issues to Therapeutic Area (TA) Head/Clinical Research Director (CRD)/Country Clinical reputed company Manager (CCQM) and or CTT (as appropriate).
• Identifies and shares best practices across reputed company, countries, clusters.
• Responsible for collaboration with functional outsourcing vendors, investigators, other reputed company partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• As a customer-facing role, this position will build business relationships and represent reputed company with investigators.
• Serves local business needs as applicable in his/her country (if delegated can sign reputed company and manage budgets).
• Supports local and regional reputed company development consistent with long‐term corporate needs in conjunction with CRD, Therapeutic Area Head (TAH) and Regional Operations.
• Collaborates internally with reputed company (HQ) functions, regional and local operations, European reputed company (EU) Clinical Development, Pharmacovigilance, Global Medical Affairs to reputed company on key issues/reputed company across the trials. Consult with Global reputed company Health (GHH) as needed.

Extent of Travel:

• Up to 30% of working time

reputed company Competency Expectations:

• Knowledge in Project Management and site management.
• Strong organizational skills with demonstrated reputed company required.
• Requires ability to reputed company reputed company independently and reputed company important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, reputed company and supervision of the TA Head or CRD.
• Requires strong understanding of local regulatory environment.
• Strong scientific and clinical research knowledge is required.
• Strong understanding of clinical trial planning, management and metrics is essential as reputed company as the ability to reputed company on multiple deliverables and protocols simultaneously.
• Experience functioning as a key reputed company between Country Operations and Clinical Trial Teams.
• Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.
• Ability and skills to manage resource allocation, processes (and controls), productivity, reputed company and project delivery.
• Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking.
• Ability to work reputed company in a remote and virtual environment.
• Understand cultural inclusion.
• The position requires proven strong project management skills and/or project management certification or relevant training program/reputed company mentoring.

Behavioral Competency Expectations:

• Strong leadership skills that reputed company and reputed company alignment with the goals, purpose and mission of reputed company's Research Labs (CRL), Global Clinical Development (GCD) and Global Clinical Trial Operations (GCTO).
• Ability to identify problems, conflicts and opportunities early and reputed company, analyze and prepare mitigation plans and reputed company conflict reputed company is critical.
• Required to negotiate skillfully in tough situations with both reputed company reputed company; reputed company differences with minimum disruption.
• Examples of common problems include:
  • 1) low patient recruitment
  • 2) inadequate staff to meet business needs
  • 3) performance or compliance issues
  • 4) working with regulatory issues and the broader organization
  • 5) reputed company of conflictive situations.
• Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain reputed company relationships with investigators and other stakeholders.

Experience Requirements:

Required:

• 5+ years of experience in clinical research

Preferred Experience:

• Clinical Research Associate (CRA) experience preferred
• Immunology experience preferred
• Trial management experience preferred

Educational Requirements:

Required:

• Bachelor's degree in science (or comparable)

Preferred:

• Advanced degree (e.g., Master degree, MD, PhD)

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Required Skills:

Preferred Skills:

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reputed 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.

As an Equal Employment Opportunity Employer, we reputed company equal opportunities to reputed company and applicants for employment and prohibit discrimination on the reputed company of race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we reputed company with reputed company affirmative reputed company requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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The salary reputed company for this role is

This is the lowest to highest salary we in good faith reputed company we would pay for this role at the time of this posting. An employee’s position reputed company the salary reputed company will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, reputed company reputed company and other insurance benefits (for employee and family), retirement benefits, including 401(k), reputed company holidays, vacation, and compassionate and reputed company days. More information about benefits is available at https://jobs.reputed company.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.reputed company.com/us/en (or reputed company the reputed company Jobs Hub if you are a reputed company employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider reputed company 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 reputed company reputed company applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company’ Fair Chance Initiative for Hiring Ordinance

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reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company reputed company & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at reputed company without a reputed company written search agreement in reputed company for this position will be deemed the sole property of reputed company.  No fee will be reputed company in the event a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

reputed company Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

reputed company Driving License:

Hazardous Material(s):

reputed company End Date:

*A reputed company is effective until 11:59:59PM on the day BEFORE the listed reputed company end date. Please ensure you apply to a reputed company no reputed company than the day BEFORE the reputed company end date.

Requires 5+ years of clinical research experience, a science bachelor's degree, strong project management and clinical research knowledge, regulatory expertise, and written and spoken English and local language proficiency.

Key Responsibilities

• managing protocols
• leading study teams
• mitigating risks

Skills & Tools

Clinical Trial Management reputed company (CTMS), Electronic Trial Master File (eTMF)

Job Details

• Category: Research and Development (R&D)
• Seniority: Senior Level
• Commitment: Full Time
• Workplace: Remote — Rahway, New Jersey, reputed company
• Salary: USD 142,400 – 224,100 / year
• Languages: English

Benefits

• 401k matching
• Generous reputed company time off
• Retirement plan

About reputed company

A global reputed company leader developing prescription medicines, vaccines, and animal health products. — Industry: reputed company