The preferred location for this role is in the San Francisco Bay area however, we are open to considering other locations as well. Supervisor, Lab Support
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Primary Responsibilities
- Provide management of clinical specimens by planning, organizing, and overseeing the collection and shipping of samples from investigator sites or Central Labs and their subsequent delivery to assay laboratories to ensure timely delivery and optimal analyzable quality
- Maintain oversight of all study sample operational activities and regularly report on status, including sample collection and reconciling against consent.
- Manage the relationships with laboratory vendors, including forecasting and tracking of study costs associated with sample management
- Review protocol and Informed consent form to ensure feasibility of biological sampling and alignment with ICH/GCP and sample testing plans
- Review of laboratory manuals and laboratory specification materials to ensure accuracy and consistency with the study protocol and clinical needs
- Participate in CRF development to ensure laboratory sample information is collected for sample tracking and reconciliation purposes
- Draft RFPs and manage scopes of work in support of study objectives for central and specialty labs
- Develop study-specific sample management plans to document cross-functional agreements on the lifecycle and reconciliation plan for each sample type
- Facilitate sample shipments and query resolution among vendors to ensure timely data delivery and provide the support sample analysis data transfer, data reconciliation, and data review. The Clinical BioSample management personnel will have at least five (5) years of relevant experience.
Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
• Supervise all activities related to work unit operations according to their field of expertise.
• Communicate the necessary information to keep the team and manager abreast of the work unit's plan, projects, processes and results.
• Make recommendations to manager in order to meet arising needs.
• Help manager to analyze the work unit's performance indicators according to established objectives. Identify opportunities for improvement in order to amend the work plan and processes. Suggest actions in order to improve efficiency.
• Supervise work unit’s activities and monitor productivity, facilitate knowledge development and transfer, and ensure the team's efficiency in order to achieve expected results.
• Act as a resource for technical questions.
• Responsible for additional departmental functions (SOP, training, job aids, etc).
• Set priorities and schedule activities of departmental resources, implement company objectives, and create alternative solutions to address business and operational challenges.
• Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching. Qualifications What we’re looking for
• Bachelor degree (biology science related field preferred)
• Relative alternate certification may be considered acceptable.
• Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel.
• Excellent communications, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Experience in regulatory context will be considered an asset.
• Ability to travel as necessary (approximately 10%).
• English level: Required bilingualism includes understanding various messages, exchanging verbally on subjects related to the tasks to be executed, and writing simple messages. Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health . Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
As a healthcare company we have an important responsibility to protect individual and public health. Except in those locations where state or local law impacts this vaccination requirement, this position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities unless an exemption can be confirmed based on a medical condition, sincerely-held religious belief, or other reasons recognized by applicable law. Submission and approval of an exemption request does not necessarily guarantee that an accommodation can be provided for any specific job.