Covance Start-up Project Manager, Moscow in Moscow, Russia
The Start-Up Project Manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client.
The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. Ability to indirectly influence investigators, vendors, external partners and country managers to deliver these commitments is a must. This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country based regulations, laws and procedures with minimal support from the client management. The position requires skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.
The position requires the ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
Accountable for execution and oversight of local operational clinical trial activities for assigned protocols in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally
Ownership of country and site budgets; development, negotiation and completion of Clinical Trial Research Agreements; oversight and tracking of clinical research-related payments; payment reconciliation at study close-out; oversight and maintenance of financial systems
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; interactions with IRB/IEC and Regulatory Authority for assigned protocols
Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments; responsible for quality and compliance in assigned protocols in country; contribution to the development of local SOPs; overseeing Clinical Trial Coordinators as applicable
Coordinates and liaises with Country Research Manager, Clinical Trial Coordinator, Clinical Research Associate, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements and local milestones; collaborates closely with Regional Operations to align country timelines for assigned protocols
Oversight and coordination of local processes; clinical and ancillary supplies management, im- 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 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 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
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
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.
Job Number 2018-18207
Job Category Clinical Operations
Position Type Full-Time
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