Senior Clinical Operations Manager

About the position

Responsibilities

• Supervises and coordinates the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Managers (CT Mgrs), Clinical Trial Monitors (CTMs), Clinical Trial Associates (CTAs), Site Relationship Managers, Study Start-up Specialists and/or Site Contract Leads 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).
• When managing all RCO staff in a given country, will represent RCO in local leadership discussions at the affiliate level and may be member of the local affiliate leadership team managed by the General Manager.
• Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and /or Heath Authorities as needed.
• Manage partnerships with critical accounts / sites.

Requirements

• Bachelors required preferably within life sciences or equivalent.
• Minimum of 5 years Pharmaceutical industry experience in Clinical Research or Medical Affairs.
• For CT Monitor Line Managers - Prior monitoring experience required.
• 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.

Nice-to-haves

• 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, 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, Clinical Trial Management Systems).

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

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