Beijing - Field
Job ID: 2973819851
Manage the local Study Start-Up Team
• Maximize productivity and contribution of the local Study Start-up Team, through effective
management of performance, communications and relations, as well as the development and
training of individual personnel.
• Guarantee that every local Study Start-Up Specialist knows their area of responsibility and
• Identify future resource needs. Recruit, train and develop the appropriate talent.
• Develop strategies for the Study Start-Up Specialists based on the global objectives and
identified areas for improvement in the countries he/she leads.
Ensure the correct execution of study start-up activities.
• Coordinate, guide and assist in all the start-up activities prior to the site's activation,
including local sample application and permit submission processes.
• Be up to date in the related regulatory knowledge to guarantee adherence and compliance
with regulatory requirements and the corresponding related documentation.
• Keep the available data (metrics), to ensure that the processes are carried out, efficacy is
promoted, and times are reduced in the study start-up phase and in contract negotiations.
• Ensures that the information and requirements of the study start-up phase are updated and
available at the central repository for the global and local study teams.
• Maintains and analyzes the metrics of the study start-up phase in order to identify trends and coordinate initiatives for improvement.
Acts as main contact with the relevant authorities related with clinical trials in the country in
order to improve the study processes, government policies / laws, through innovative
• Keeps updated and informed of the changes in the clinical study start-up process in
government, in research sites and in the industry in general and cascade this information
with the Study Start-up Team.
• Ensures that all information requested by the Regulatory Authorities / Industry Bodies/ EC
is provided as appropriate and in a timely manner.
• Ensure continuous and proactive communication with the Ethic’s Committees/Hospital
Administration/Industry Bodies, in order to obtain precise and updated information on the
status and activities of clinical studies.
• Act as a main contact of the Study Start-up Team with the legal/regulatory/medical affairs
• Ensures the correct guidance to the CSM and CSS on regulatory / ethics issues.
• Coordinates collaboration with the Local Vendor Manager, to provide information as
required, regarding the identification, selection and follow-up process for vendors.
• Act as country representative in the SSU network within the region / organization.
Identification of new sites
• Assists in the identification of new sites with the collaboration of Country Study Managers.
• Perform/coordinate site level feasibility activities including evaluation of patient population
and final site selection.
• Ensure the correct budget negotiation with the study sites.
• Ensure adherence to FMV (Fair Market Value) for all clinical trials costings and payments.
• Ensure cost effectiveness and development of global / local tools and templates that
facilitate this in the affiliates.
• University Degree or Equivalent preferably in a medical/science-related field.
• Prior work experience demonstrating knowledge and understanding of clinical trials, such as
that obtained in a clinical trial monitor capacity, and experience managing projects.
• Demonstrated knowledge and understanding of ICH-GCP/GPP, the regulatory, ethics and
contractual requirements for starting clinical trials in relevant country.
Skills, Experience and Competencies
• Decision making - Pushes decision making to the lowest appropriate level and develops
employees’ confidence in their ability to make those decisions
• Encourages direct and open discussions about important issues.
• Managing change - Effectively manages change; explaining the context, answering questions,
and patiently listening to concerns
• Teamwork collaboration - Finds and attracts highly talented and productive people
• Achieving results - Clearly conveys objectives, deadlines and expectations
• Ability to present clear messages accurately in both written and spoken English from
complex information/data to all levels in the organization
• Availability to travel domestically and internationally if required.
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.Read Full Description