local start up ManagerLaboratory Corporation of America

Essential Job Duties:
On the Client level:
FINANCIAL (as applicable):
Ownership of country and site budgets.
Development, negotiation and execution of Clinical Trial Research Agreements (CTRA).
Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
Oversight and tracking of clinical research-related payments
Payment reconciliation at study close-out.
Oversight of FCPA, Denied Parties Screening and maintenance of financial systems.
Financial forecasting and tracking of operational budget in conjunction with the client manager.
COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS (as applicable):
Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
Development of local language materials including local language Informed Consents and translations.
Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.
Deliver the expertise in country based regulations, laws and procedures
Provide an oversight and tracking of clinical research-related payments
Overlook payment reconciliation at study close-out
MANAGEMENT & QUALITY OVERSIGHT:
Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments.
Contributes to the development of local SOPs.
May oversee contract workers and local vendors as applicable.
COLLABORATION:
Works in close collaboration internally with Clinical country operations (CRD, CRM,CTC,CRA), Country Quality Manager (CQM), Finance, Medical Affairs, Regulatory Affairs, PharmacoVigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
LOCAL PROCESS OVERSIGHT: (as applicable):
Oversight and coordination of local processes & SOPs
Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
Enters and updates country information in clinical, regulatory, safety and finance systems.
Education/Qualifications:
Minimum Required:
University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
In lieu of the above requirement, candidates with minimum of eight (8) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
Thorough understanding of the drug development process
Fluent in local office language and in English, both written and verbal
Experience:
Minimum Required:
Good organizational and time management skills
Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
Excellent communication skills, oral and written.
Self-motivation with the ability to work under pressure to meet deadlines
Works well independently as well as in team environment.
Detail and process oriented
Positive attitude and approach
Interact with internal and external customers with high degree of professionalism and discretion
Multi-tasking capability.
Good computer skills with good working knowledge of a range of computer packages
Ability to lead and develop junior staff
Flexible and adaptable to a developing work environment
Problem solving and Process Improvement is essential to this position. Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
Minimum of eight (8) years of clinical research experience
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
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Laboratory Corporation of America

Manila City, Metro Manila
Permanent
Full-time