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.
The position manages all aspects of clinical trial operations in a country and will manage exquisite execution of all interventional clinical trials as well as oversight of Local Clinical Evaluations (LCEs) of an interventional nature and CRO run studies. Will adhere to Good Clinical Practices (GCP), local and global policies and procedures to conduct high-quality, inspection ready studies. The position will manage the trial quality, audit responses and the completion of Corrective Action and Preventive Action (CAPAs).
The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across all phases within the country. The position has multiple touchpoints with Global Clinical Trial Operations (GCTO) and company Research Labs staff in our headquarters. Additionally, there are important interactions with, inter alia, Quality Assurance, Finance, Regulatory, Clinical Supplies and legal in a highly matrix-based organization. There are some interfaces with Human Health/Global Medical Affairs (GMA).
Provide Leadership to the country(ies): Build the best team and chart the course. This includes continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management, and oversight of all high priority programs and studies.
Adhere to company standards and Research Laboratory/Global Clinical Development (GCD) and GCTO goals, initiatives, and expectations.
Manage Clinical Operations activities and personnel within the country/cluster. Ensure that compliance, quality, and timeline objectives are met for all trials executed in the country.
Work collaboratively in a matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs)
Engage with Functional Service Provider (FSP) Senior, Regional and local team to ensure adequate and appropriate resourcing for the company's internal clinical trial portfolio
Partner with Clinical Research Organization (CRO) Senior, Regional and local team to ensure the successful implementation of fully outsourced clinical trials - Work with the Global Operations group within GCTO and Global Medical Affairs as appropriate, in site management and selection decisions.
Develop and manage Investigator relationships in conjunction with the research laboratory Therapy Areas, and when appropriate, Human Health colleagues. Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with KOLs, etc.).
Manage clinical audit outcomes, working closely with the Quality Assurance group and the Good Clinical Practice Quality and Compliance Council (GCP QCC).
Represent GCTO and the country on strategic initiatives at all levels of the organization. Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve GCTO, GCD, and research laboratory objectives. Sets clear performance standards and holds self and organization accountable for achieving results. Embraces GCTO metrics and performance standards (KPI’s)
Represents the GCTO organization both internally and externally within the industry
Ensure appropriate scientific and operational training for staff members
Core Competency Expectations:
Significant Management background in a Clinical Trials setting with the ability to service and engage with different stakeholders within GCTO and research laboratory in a matrix organization.
Management expertise should cover management of budget, travel, resources, headcount, processes (and controls), productivity, quality, and project delivery
Complete awareness of the International Conference on Harmonization Good Clinical Practice (ICH GCP) and Global/Regional/Local regulatory requirements are needed.
Strong communication skills requiring proficiency in written and spoken English.
Behavioral Competency Expectations:
High emotional intelligence
Strong leadership that will attract, motivate, inspire, develop, and retain talented staff. In addition, will enable and drive alignment with the goals, purpose, and mission of our company's Research Labs, Global Clinical Development (GCD) and GCTO
Positive proven success in people management
10+ years in Clinical Trial Operations gained from working at hospitals and/or research institutions, recognized clinical trial suppliers/vendors, reputable CRO(s), and/or a Sponsor environment working on multi-phase, multi-therapeutic, and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation
Required: Bachelor’s degree in life sciences combined with the consistent contribution to and delivery of clinical trial execution
To make a difference in the lives of people globally through our innovative medicines, vaccines, and animal health products. We are committed to being the premier, research-intensive biopharmaceutical company and are dedicated to providing leading innovations and solutions for today and the future.