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Project Manager, Start-Up

3 meses atrás

São Paulo, São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Job Overview:

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. The 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.

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 a 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.

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

• 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 and in a team environment.

• Detail and process oriented

• Positive attitude and approach

• Interact with internal and external customers with a 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.

• 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:
o Issues in budget / CTRA negotiations
o Quality and compliance issues
o Regulatory and legal issues
o Issues related to functional area deliverables that could jeopardize protocol milestones.

Preferred Qualifications Include:


• Master or other advanced degree

• PMP certification

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.