The Associate Local 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 .
Assignment of site numbers
Identification of patients documents required for translation
Assessment of local sourcing availability of drug
Start-up timelines estimation
Oversight and coordination of CTC tasks during validation (support)
Coordination of collection of site documents required for EC / HA submission
Local ICF adaptation
Review and adaptation of patient recruitment and retention materials
Cooperation and support of contract / financial team during contracting process
Providing update to study team members, i.e. CRM, CRAs, RCPM, CTC regarding current start-up status
Local IMP, drug and non-clinical supplies management
Coordination of preparation of ITFB
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 four (4) 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
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
Significant clinical research experience
Job Number 2018-22094
Job Category Clinical Operations
Position Type Full-Time
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