Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Global Studies Manager

Expired Job

Bayside Solutions South San Francisco , CA 94080

Posted 3 months ago

Bayside Solutions is seeking a Global Studies Manager to be part of our client s team in South San Francisco. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients lives.

Our Client s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients lives. This could explain why their company has been recognized as one of the Top Twenty Employers in biotechnology and pharmaceuticals by Science Careers. The Global Studies Manager will provide the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.

Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California.

The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.

You can find additional information on our company website at

Global Studies Manager

Job Benefits:

An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
Work for a company that is local to the bay area and recognized as a leader of innovation.
Competitive compensation commensurate with experience.
This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of


Ensures study adherence to ICH/GCP and SOPs.
Identifies areas of best practice and process improvements.
Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work.
Contributes to the development and management of the study timelines, resources, budget, risk and quality plans.
Provides direction and leadership to one or more clinical operations teams.
Summary of


Degree in Life sciences or nursing equivalent is required.
5-7 years of experience in clinical research/healthcare environment.
Must be an experienced GSM with 5+ years of study management experience.
Proven ability in clinical development of the operational aspects of all stages of clinical trials.
Experience in Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock is preferred.
Strong knowledge of ICH GCP is a must.
Must be flexible to some travel.
Strongly proficient with computer skills.
Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans.
Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.
Well-developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.

See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Global Clinical Trial Manager

Cytomx Therapeutics

Posted Yesterday

VIEW JOBS 11/18/2018 12:00:00 AM 2019-02-16T00:00 Global Clinical Trial Manager About CytomX Therapeutics: CytomX Therapeutics is a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody™ therapeutic technology platform. Probody therapeutics are designed to exploit unique conditions of the tumor microenvironment to more effectively localize antibody binding and activity while limiting activity in healthy tissues. The Company's pipeline includes cancer immunotherapies against clinically-validated targets, including a PD-L1-targeting Probody therapeutic wholly owned by CytomX (CX-072), a PD-1-targeting Probody therapeutic wholly owned by CytomX (CX-188) and a CTLA-4-targeting Probody therapeutic partnered with Bristol Myers Squibb (BMS-986249). The pipeline also includes first-in-class Probody drug conjugates against highly attractive targets including a CD166-targeting Probody drug conjugate wholly owned by CytomX (CX-2009), and a CD71-targeting Probody drug conjugate partnered with AbbVie (CX-2029) are among cancer targets that have been considered to be inaccessible to conventional antibody drug conjugates due to their presence on many healthy tissues. CytomX and its partners have four programs in the clinic. In addition to its wholly owned programs, CytomX has strategic collaborations with AbbVie, Amgen, Bristol-Myers Squibb Company and ImmunoGen, Inc. For more information, visit Follow us on Twitter and LinkedIn. Location: South San Francisco, California Reporting Relationship: Reports to Director, Clinical Operations The Opportunity: The Global Clinical Trial Manager is responsible for providing operational and scientific support for Clinical studies and Development activities. This cross-functional role includes working directly with the study team and vendors to ensure execution on the clinical strategy, as well as assembling, evaluating, and presenting scientific and operational data, assisting with writing manuscripts (paper, abstracts, posters, etc.), and reviewing and summarizing relevant literature. The Global Clinical Trial Manager will report to the Vice President, Clinical Operations and collaborate closely with Clinical Development, Clinical Pharmacology, Biostatistics, Data Management and Project Management. Major Duties/Responsibilities * Develops, leads and coordinates clinical trial operational activities and manages their execution to ensure completion according to timelines, anticipating potential study problems and preparing contingency plans as needed * Work directly with vendors to ensure development and delivery of study documents, plans and manuals * Partners with study team to ensure trial activities are documented in the trial master file in accordance with regulatory requirement and SOPs * Coordinate cross functionally and manage the development of Module 5 submission documents, protocols, and amendments and ICF's * Work collaboratively with project teams to incorporate the therapeutic directions and patient selection strategies into clinical protocols * Support the Medical Monitor with the development of program documents, including the clinical sections of various regulatory documents such as clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions * Develop and cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors * Collaborate with the clinical development team to ensure appropriate data review and accurate data reporting * Work cross functionally to assist in the preparation of data and contribute to scientific publications including posters, abstracts and manuscripts * Support the implementation of new clinical systems/processes * May mentor, manage and develop other team members Education/Experience: * A minimum of a Bachelor's degree in clinical, biological, mathematical sciences or related field is required, an advanced degree is preferred. Equivalent experience may be accepted in lieu of the degree requirement * A minimum of 3 years pharmaceutical development experience is strongly preferred Professional Requirements: * Excellent written and verbal communication skills are required * Experience and understanding of ICH and GCP is preferred * Up to 20% travel Personal Characteristics: * Must have demonstrated problem solving abilities and strong organizational skills * Must be a demonstrated self-starter and team player with strong interpersonal skills CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. Cytomx Therapeutics South San Francisco CA

Global Studies Manager

Expired Job

Bayside Solutions