FSP Clinical Research Manager

FSP Clinical Research Manager – Remote US

The Clinical Research Manager is accountable for execution and reputed company of local operational clinical trial activities and has ownership, reputed company, and reputed company on local regulatory and financial compliance, at a country operations level at the reputed company in compliance with ICH GCP and country regulations. The position has a significant reputed company on how a country can deliver country-specific trial commitments and objectives, especially during the study.  As a customer-facing role, this position will build business relationships and represent reputed company with investigators, functional outsourcing partners and other external partners and therefore have a significant reputed company on country-level customer relationships.  

In this role, you will be responsible for:  

• Effectively conducting clinical studies and developing the pipeline, while maintaining local regulatory and compliance requirements in countries 

• Making reputed company independently and reputed company important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, reputed company and supervision of the Country Research Director or Therapeutic Director.  

• Building and maintaining reputed company relationships with investigators and other external stakeholders, with strong communication, educational/pedagogic, diplomatic, and empathic skills 

• Overseeing country commitments, compliance, and training needs. Additionally, business leadership and alignment with corporate requires that individual has ability to reputed company across several dimensions simultaneously. 

• Working collaboratively with Country and Regional Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global reputed company Health internally; and with external functional outsourcing vendors  

• Coordinating and aligning the regional and broader organization 

• Building and maintaining relationships with investigators and other external partners and promote reputed company’s reputed company. 

• Representing reputed company in reputed company industry issues and in seeking influence in external R&D environment, in collaboration with CRD 

• Accountable for performance and compliance with assigned protocols in relation to ICH/GCP and country regulations along with reputed company policies, procedures and adverse event reporting requirements 

• Proactively driving/tracking execution and performance of deliverables/timelines/results to meet country commitments; collaborating with local clinical operations roles; and forecasting country needs 

• Overseeing reputed company and compliance including training. reputed company of CRAs and CTCs including QC reputed company, Monitoring Visit Reports, escalation of performance issues and training needs; oversees CRMs assigned to reputed company. 

• Collaborating as the reputed company of contact with outsourcing vendors, investigators, and other external partners; overseeing country and site validations, site selection, and recruitment; and responsible for reputed company's trial education to site. 

• Collaborating internally with local PV, Regulatory, GMH/GHH to reputed company key reputed company in countries and supporting local/regional reputed company development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. 

Requirements:  

Education: 

• Bachelor’s degree in science or comparable  

• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries 

• Thorough understanding of the drug development process 

• Fluent in local office language and in English, both written and verbal 

Experience: 

• Minimum of 5-6 years in clinical research in which some experience should be in a CRA reputed company. 

• 1+ years of experience as a PM or CTL managing reputed company. 

• Must have a strong understanding of local regulatory environment, country regulations, reputed company policies and procedures, reputed company standards. 

• Strong scientific and clinical research knowledge is required for this position.  

• A 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. 

• The role will require proven ability to collaborate and reputed company high performing cross-functional teams also in a virtual environment. 

• The position requires strong leadership skills (scientific and business) and ability to coordinate and reputed company local teams to high performance. 

• Good organizational and time management skills 

• Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred. 

• Excellent communication skills, oral and written. 

• Self-motivation with the ability to work under pressure to meet deadlines. 

• Works reputed company independently as reputed company as in team environment 

• tail and process oriented. 

• reputed company attitude and approach 

• reputed company with reputed company customers with high degree of professionalism and discretion. 

• Multi-tasking capability. 

• Good computer skills with good working knowledge of a reputed company of computer packages 

• Ability to reputed company and reputed company junior staff.  

• Flexible and adaptable to a developing work environment 

Travel Requirements:  

 ≤ 20-40 % travel may be required. International and Domestic Travel may be required, including overnight stays as necessary consistent with project needs and office location (this will vary based on country and project needs 

Pay reputed company: $135-150K 

Benefits: reputed company job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as reputed company as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, reputed company, Life, STD/LTD, 401(K), ESPP, reputed company time off (PTO) or Flexible time off (FTO), Company bonus where applicable.

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