Clinical Trial Coordinator (CTC) Manager (REMOTE)

Job Description

Our Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

Under the oversight of the Clinical Research Director (CRD), this position will manage a team of Emerging Talent CTCs (ET-CTC)and/or Emerging Talent Rotation Associates (ETRAs). This position will also work to ensure excellent study administrative performance with strict adherence to local regulations, company Standard Operating Procedures (SOPs) and International Conference on Harmonization Good Clinical Practice (ICH GCP).

As line manager, the role is critical to continuously develop future talent by providing training and mentoring to the CTCs, as well as overseeing the Intern to Hire and Summer Intern candidate program while properly managing situations of low or non-performance. The role will work at the country level with other local stakeholders e.g. Clinical Research Manager (CRM) and CRD to ensure alignment and development of the country's CTC capabilities. The role will engage with country Partner Line Manager (PLMs) and CRMs to ensure alignment across all monitoring therapeutic areas. The person contributes to CTC capacity/resource planning activities to ensure the efficient allocation of resources and work.

Primary duties include, but are not limited to:

• Ensure and oversee proper on‐boarding and off‐boarding of employees, compliance with initial and ongoing training.

• Train and oversee the core competencies, ICH‐GCP knowledge, clinical research environment, monitoring etc.

• Assure adherence to GCP guidelines, processes, and procedures related to direct reports’ activities and performance.

• Ensure direct reports are compliant to the timelines and key business metrics.

• Review and approve timesheets, Global Time Tracking compliance, expense reports, timeoff requests and provide proper oversight of CTC's productivity/utilization.

• Provide input for capacity planning, including reporting of current manpower and forecasting of CTC capacity and needs, to provide efficient use of resources.

• Work with CRDs, CRMs, CRAs, PLMs, and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.

• Interacts with CRMs and sites as needed to resolve operational issues, to meet commitments in a timely manner and in coordination with the study CRM and Clinical Research Associate (CRA).

• Interface with Global Clinical Trial Operations (GCTO) partners on clinical trial execution as assigned; acts as liaison with CTC Functional Service Providers partners in facilitating the coordinated process and product delivery.

• Escalates site performance issues to CRM and Clinical Research Director (CRD).

• People and Resource Management

• Support and manage CTC – career development, performance reviews, etc., including addressing low-performance situations, and taking appropriate actions.

• Manage and resolve escalation of issues from CTCs.

• Contribute to Headquarter capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resources and work.

• Ensures CTC compliance to corporate policies, procedures, and quality standards

Core Competency Expectations:

• Ability to work independently and in a team environment

• Excellent people management, time management, project management, and organizational skills

• History of strong performance and leadership

• Skills and judgment to be a good steward/decision-maker for the company

• Fluent in Local Language and business proficient in English (verbal and written)

• Excellent working knowledge of all applicable ICH/GCP regulations and Good

• Documentation Practices and the ability to work within these guidelines

• Expertise in and excellent working knowledge of core trial management sy tems and tools

Behavioral Competency Expectations:

• High emotional intelligence

• Strong leadership skills with proven success in people management

• Excellent interpersonal and communication skills, conflict management

• Demonstrated ability to build relationships and to communicate effectively with external customers (e.g. sites and investigators)

• Influencing skills

Experience needed:

• Minimum of 5 years within Clinical Research

• Minimum of 3 years as CRA monitoring clinical trials

• Background in line management or team lead preferred

Educational Qualifications:
Required:

• BA/BS degree with emphasis in science and/or biology

Preferred:

• Advanced degree

#eligibleforerp

ResearchandDevelopmentGCTO

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

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Available benefits include 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. A summary of benefits is listed here.

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

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