Job Description:
The Study Start-Up Manager provides operational expertise and customer focused leadership to multiple operations teams involved in start-up and activation activities. Ensuring the effective and efficient delivery of all operational aspects of multiple studies through all phases of start-up. This oversight and management may be for a country, region or global. The Study Start-Up Manager does so in accordance with applicable Veristat Policies, Standard Operating Procedures (SOPs), conventions and instructions, as well as current Good Clinical Practice (GCP), International Conference on Harmonization (ICH) and all applicable country and local regulations.
Make an Impact at Veristat!
Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.
- 105+ approved therapies for marketing applications prepared by Veristat
- 480+ oncology projects in the past 5 years
- 350+ rare disease projects delivered in the past 5 years
- Flexible, inclusive culture — 70% remote workforce, 66% women-led teams
Learn more about our core values here!
What we offer
Benefits vary by location and may include:
o Remote working
o Flexible time off
o Paid holidays
o Medical insurance
o Tuition reimbursement
o Retirement plans
What we look for
- Bachelor’s degree in a relevant field required; biological science, Pharmacy, Nursing, or related field preferred.
- 4 to 6 years in Clinical Operations or similar department required, with experience leading project teams to success.
- SOCRA or ACRP certification and/or membership preferred.
- Thorough knowledge of clinical operations, clinical development process, and ICH/GCP and regulatory environment.
- Excellent communication skills and attention to detail within a fast-paced office environment required.
- Willing and able to work well in a matrixed environment, across departments, across levels, amongst competing priorities and multiple stakeholders (both internally and externally).
- Expert skills in Microsoft applications.
- Proven clinical development experience in the operational aspects of clinical studies, including the ability to lead, motivate, mentor, coach and train assigned team members.
- Excellent oral and written communication skills in English (other languages a plus), to effectively support and manage exchanges with external customers.
Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.
Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Skills Required
- Bachelor's degree in a relevant field
- 4 to 6 years of experience in Clinical Operations or a similar department
- Experience leading project teams to success
- Thorough knowledge of clinical operations and the clinical development process
- Knowledge of ICH/GCP and the regulatory environment
- Excellent communication skills and attention to detail
- Ability to work effectively in a matrixed environment across departments, levels, and stakeholders
- Expert skills in Microsoft applications
- Proven clinical development experience in the operational aspects of clinical studies
- Ability to lead, motivate, mentor, coach, and train team members
- Excellent oral and written English communication skills
- Biological science, Pharmacy, Nursing, or related field
- SOCRA or ACRP certification and/or membership
- Additional language skills
What We Do
Veristat is the science-first full-service drug and biologic CRO and consultancy that integrates strategic planning, regulatory expertise, and clinical trial execution to rapidly advance the most complex or novel therapies. At Veristat, we collaborate with clients to support the rapid delivery of life-changing therapies, helping them make sound decisions amidst uncertainties. Our scientific experts design and conduct the global activities required for any clinical, regulatory, or commercialization program comprehensively and efficiently. With our focus on novel drug development and nearly 30 years of experience, our versatile approach and bold scientific thinking make the impossible possible. Depend on our game-changing expertise and reliable execution for fast results and positive impact to support your biologics and drugs to treat rare cancers, CNS/Neurological disorders, Endocrine/metabolic disorders, and infectious diseases. We are…Bold. Scientific. Versatile. Veristat. - Veristat has recently been made aware that unknown third parties that have no connection to Veristat are generating fake Veristat job postings, interviews, and even fake employment offers via emails, websites, and various social media platforms, seemingly for the purpose of fraudulently obtaining personal information from legitimate job candidates. All legitimate correspondence from Veristat will originate from our applicant tracking system (Jobvite) or an @veristat.com email address. If you have received outreach from someone claiming to be a member of our team please search our official LinkedIn company page (https://www.linkedin.com/company/veristat-llc), where all members of our authorized recruiting team can be identified, or contact us directly at [email protected]. Be vigilant
