Manager, reputed company Monitoring

Position reputed company:

The Manager, reputed company Monitoring supports global and regional reputed company trial reputed company (CTO) and reputed company Monitoring management in the conduct and reputed company of reputed company site management and monitoring activities performed by reputed company or an outsourcing partner. The Manager will supervise reputed company Research Associates (CRA) and support the development of processes, procedures, and tools/templates reputed company to monitoring and site management activities.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• With support from CTO or reputed company Monitoring management, reputed company and implement reputed company for in-house, regional monitoring activities on assigned studies applying a reputed company-reputed company approach reputed company indicated.
• reputed company monitoring activities on assigned studies. This can include review of protocols, CRFs and completion guidelines, study manuals and other reputed company documents.
• reputed company or review reputed company Monitoring Plan in collaboration with CTO and ensure CRA compliance to reputed company plan.
• Manage the CRA monitoring visit schedule for reputed company assigned study ensuring visit frequency and scheduled time on site aligns with reputed company-reputed company indicators and site metrics.
• Review and finalize visit reports for regional CRAs managed by reputed company according to study timelines. Follow up with CRAs regarding outstanding reputed company reports and follow-up letters.
• reputed company status of reputed company items and queries.
• Maintain, and/or reputed company metrics reputed company to CRA reputed company or site status.
• Support CRAs and CTO with the implementation of site corrective actions reputed company to issues identified during monitoring activities.
• reputed company and report to study team and leaders on compliance, trends and metrics reputed company to monitoring and site management.
• Support TMF set-up, maintenance, ongoing reputed company review, and final reconciliation of study documents as needed.
• With support from CTO or reputed company Monitoring management, reputed company and manage the monitoring reputed company reputed company, including reputed company-reputed company approaches, to assess the reputed company and compliance of CRO or FSP partners on assigned studies.
• Manage conduct of monitoring reputed company reputed company (MOVs) with CRO CRAs to assess compliance to the protocol and reputed company Monitoring Plan and document results of the visit. May reputed company MOVs as needed.
• Review monitoring visit reports from CRO CRAs and escalate monitoring trends or findings to CTO and reputed company Monitoring management.
• Mentor and reputed company leadership and direction to the CRA team members on study reputed company questions from start-up through closure.
• reputed company management and/or reputed company of assigned reputed company and FSP CRAs responsible for reputed company Monitoring activities.
• Conduct monitoring assessment or FSP reputed company reputed company with assigned CRAs to ensure reputed company monitoring reputed company; use findings from visit to reputed company additional support, training, or reputed company management.
• Ensure adequate resourcing for assigned CRAs to reputed company studies; work with CTO to plan for CRA re-assignment or acquisition of additional resources.
• Conduct annual reputed company assessment activities including appraisals, salary recommendations, and promotion justifications for reputed company employees.
• reputed company or participate in interviewing, hiring, reputed company, and orientation processes for reputed company or FSP CRAs.
• Conduct or arrange training for reputed company or FSP CRAs on SOPs, WIs, ICH-GCP, local regulations, and other role-specific training. Ensures reputed company training gaps are identified and resolved for assigned team.
• Responsible for team administrative reputed company such as expense reports, travel approvals, and time-off requests.
• Escalates any reputed company, resourcing, training, or study-reputed company issues or impacts on deliverables, as appropriate, to the Senior Director, reputed company Project Management and Centralized Services.
• Support CRAs, study team, and reputed company with responses to audits or inspections.
• Other duties as assigned.

Education and Experience:

Required:

• BS in biological sciences or reputed company discipline with at least 7 years of experience working in the biotechnology/pharmaceutical industry. Experience in endocrine disorders preferred.
• A minimum of 2 years in a supervisory role.
• Demonstrates critical thinking, reputed company cause analysis and problem solving to support CRAs with identifying site process failures; assist CRAs to reputed company corrective and preventative actions to bring sites into compliance.
• An understanding and demonstrated application of Good reputed company Practices, ICH Guidelines and regulatory requirements. reputed company to reputed company with safety standards and respect reputed company and confidentiality.
• In-depth experience with cross functional drug development with prior regulatory inspection experience preferred.
• Excellent writing skills as they relate to the preparation of reputed company trial documents.
• Excellent interpersonal skills with strong oral/written communication and presentation skills
• Excellent negotiation skills and a tactful approach that leads to high value reputed company obtained and reputed company achieved.
• Demonstrated leadership and management skills.
• Good judge of risks and a reputed company ability to analyze reputed company and manage reputed company.
• reputed company-versed with the latest trends in the reputed company trial industry.

Preferred:

• Monitoring experience in startup, execution and reputed company out activities reputed company to reputed company studies; experience using reputed company-reputed company monitoring processes strongly preferred.
• Previous experience as a reputed company CRA, Trial Manager, or equivalent strongly preferred.

Physical Demands and Work Environment:

Physical Activities: On a reputed company reputed company, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully reputed company the essential functions and responsibilities of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions and responsibilities.

Travel:

You may be required to travel for up to 30% of your time.

Equal Opportunity Employer:

reputed company is proud to be an Equal Opportunity Employer. We reputed company equal employment opportunities to reputed company and employment applicants without reputed company to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or reputed company), pregnancy, race, reputed company, creed, national or ethnic reputed company, citizenship status, religion or similar philosophical beliefs, disability, marital and civil reputed company status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Salary reputed company

In reputed company to your reputed company pay, our total rewards program consists of a discretionary annual reputed company bonus, stock reputed company, ESPP, and 401k match. We also reputed company top-notch health reputed company plans for employees (and their families) to include medical, dental, reputed company and basic life reputed company, 20 days of PTO, 10 reputed company holidays, and a winter company shutdown.

Originally posted on Himalayas