Line Manager SSU, Clinical Operations

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Line Manager-SSU, Clinical Operations

Department Title and Description:

Regional Clinical Operations (RCO)Mexico & Colombia, R&D regional organization responsible for the execution of phase I-IV clinical studies in Mexico and Colombia.

Purpose/Objective of the job:

To lead and manage Study Start-up team, ensuring delivery of clinical operations effectiveness in RCO Mexico & Colombia.

Key Responsibilities and Major Duties:

• Supervises and coordinates the work assignments and performance of Clinical Trial Associates (CTAs) and Study Start-up Specialists to ensure timely execution consistent with R&D and local research goals and priorities.
• Demonstrates the ability to effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution, problem solving and crisis management.
• Anticipates resource needs and provides workload evaluations and task assignments.
• Allocates and assign study resources in alignment with R&D and local research goals and priorities.
• Supervises clinical trial execution at country level including supervising study metrics and team performance.
• Approves study fee funds and payments based on grant of authority.
• May propose and/or validate country study targets.
• May support Health Authority inspection and pre-inspection activities.
• May support audit preparation & Corrective Action / Preventative Action preparation for local related issues.
• Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available.
• Develops goals that are consistent with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met.
• Together with the RCO management tracks and manages performance metrics for Clinical Operations staff.
• Anticipates and initiates action in response to multiple/changing demands and project priorities placed on Clinical Operations Unit
• Point of Contact for FSP staff within the country
• Managing the hiring, performance management and succession planning of staff
• Performing general and human resource administrative functions
• Participation in performance calibration and talent review meetings
• Ensuring collaboration and information sharing with local country cross functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources)
• Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and /or Health Authorities as needed.
• Manage partnerships with critical accounts / sites.

Direct line reporting responsibility for CTAs & Study Start-up Specialist roles.

Key Stakeholders/Contacts – Associate Director Clinical Operations, Line Managers Clinical Operations, Clinical Trial Managers, Clinical Trial Monitors, Site Contract Leads.

RCO Mexico & Colombia Stakeholders within Global Clinical Operations:

BMS Local Medical, GRS, GPV, Market Access, Commercial Brand Teams, Human Resources, Legal.

Local clinical trial sites

Grade Level

EG120

Manager Title:

Line Manager SSU, Clinical Operations

List of minimum requirements

• Degree/Certification/Licensure

Bachelor’s or master’s Degree within life sciences or equivalent

• Experience – Responsibility and minimum number of years:

• Minimum of 5 years pharmaceutical industry experience in Clinical Research or Medical Affairs
• Significant experience in the planning, conduct and management of clinical programs (Phase I-IV)
• Demonstrated ability to drive project related activities.
• Previous supervisory and/or leadership experience (i.e., participation in task force, initiative, or cross functional team)
• Previous resource allocation experience preferred.
• Experience mentoring and providing feedback to others.

• Competencies – knowledge, skills, abilities, other

• In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs
• In depth knowledge and understanding of clinical research processes, Mexican and Colombian regulations, and methodology.
• Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management​.
• Demonstrated organizational and planning skills and independent decision-making ability.
• Strong organization and time management skills and ability to effectively manage multiple competing priorities.
• Outstanding interpersonal, oral and written communication skills to influence, inform or guide others.
• Good verbal and written communication skills (both in English and local language).

• Software that must be used independently and without assistance (e.g., Microsoft Suite)

• Microsoft Suite
• Clinical Trial Management Systems

Working Conditions

• Travel Required (nature and frequency)

Domestic travel to clinical trial sites

International travel where required.

• Overnight Absences Required (per typical month): ~0-1
• Describe exposure to any hazards/disagreeable conditions in the work environment: Ergonomic.

#LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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