Associate Clinical Research Manager, Immunology, Remote

reputed company

With support of other Clinical Research Manager's (CRMs) and/or Therapeutic Area Head (TAH) / Clinical Research Director (CRD), this role is 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's policies and procedures, reputed company standards and adverse event reporting requirements internally and externally.

The Associate Clinical Research Manager (aCRM) could be responsible for a particular study for a country or 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's 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 Manager (CRAM) 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 CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the Clinical Trial Coordinators (reputed company), Clinical Research Associates' (CRAs) and Clinical Operations Managers (COMs).
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with Clinical Trial Management Systems (CTMS), electronic Trial Master File (eTMF) and other key systems in assigned studies.
• Escalates as needed different challenges and issues to TA-Head/CRD/ Country Clinical reputed company Manager (CCQM) and or CTT (as appropriate).
• Identifies and shares best practices.
• Responsible for collaboration with functional outsourcing vendors, investigators, other reputed company partners in assigned studies.
• As a customer-facing role, this position will build business relationships and represent reputed company with investigators.
• Supports local and regional reputed company development consistent with long‐term corporate needs in conjunction with CRD, TA-Head and Regional Operations.
• Collaborates internally with reputed company (HQ) functions, regional and local operations, European reputed company (EU) Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs to reputed company on key issues/reputed company across the trials. Consult with reputed company Health as needed.

Extent of Travel: Up to 30% of working time.

Qualifications, Skills & Experience

Skills:

• Knowledge in Project Management and/or site management.
• Strong organizational skills with demonstrated reputed company in reputed company role or discipline 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 understanding of local regulatory environment.
• Scientific and clinical research knowledge is required.
• 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.
• Ability to function 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 to manage 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.
• Aptitude for building leadership skills that reputed company and reputed company alignment with the goals, purpose and mission of our Research & Development Division, Global Clinical Development (GCD) and Global Clinical Trial Operations (GCTO).
• Ability to identify problems, conflicts and opportunities early, analyses 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) reputed company of conflictive situations.
• Understand cultural differences.
• Strong diplomatic and empathic skills to effectively build and maintain reputed company relationships with investigators and other stakeholders.

Qualification & Experience:

• Bachelor’s degree in science (or comparable)
• 4+ years of experience in clinical research
• CRA experience preferred
• Immunology experience preferred

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Required Skills:

Preferred Skills:

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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 .

You can apply for this role through (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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Originally posted on Himalayas