Study Start-up, Project Manager

Essential Job Duties:

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 paymentsPayment 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 proceduresProvide an oversight and tracking of clinical research-related paymentsOverlook payment reconciliation at study close-outMANAGEMENT & 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 & SOPsResponsible 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:

University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technologyIn 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 consideredThorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countriesThorough understanding of the drug development processFluent in local office language and in English, both written and verbal

Experience:

Good organizational and time management skillsWorking 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 deadlinesWorks well independently as well as in team environment.Detail and process orientedPositive attitude and approachInteract with internal and external customers with high degree of professionalism and discretionMulti-tasking capability.Good computer skills with good working knowledge of a range of computer packagesAbility to lead and develop junior staffFlexible and adaptable to a developing work environmentProblem 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