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

Compass Consulting Group South San Francisco , CA 94080

Posted 2 months ago

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

Main Responsibilities and Accountabilities:

Provides direction and leadership to one or more clinical operations teams
Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
Creates team culture and promotes team spirit.
Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.
In collaboration with functional management, coaches, mentors, supports and provides study specific direction to Study Management team members.
Oversees the development and maintenance of study specific manuals created by the GSA.

Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL.
Develops and manages clinical study budgets (including HQ budget) and contributes to the staffing/resourcing plans. Communicates variances in the budget and action plan for resolution to the GSL.
Establishes study milestones and ensures accurate tracking and reporting of study metrics.
Provides operational input into the development of protocol feasibility questionnaires.

Provides clinical operations expertise to ensure operational feasibility and delivery
Leads the development and finalization of site feasibility questionnaires.
Leads the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and OPL.
Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes.
Analyzes the feasibility data across countries with input from the affiliates and makes recommendations to the GSL for the strategic country and site distribution and patient numbers.

Oversees forecasting of clinical/non-clinical supplies
Designs drug assumption and supply chain process in partnership with Pharma Technical Drug Supplies, affiliates and GSL.
Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study.

Delivers the operational elements of the study plan
Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings.
Ensures that reporting of SUSARs is established and maintained for the duration of the study.
Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL and implements contingencies in consultation with the GSL.
Primary contact with affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action.
Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits.
Oversees the maintenance of drugs supplies and resolution of issues with input from the Pharma Technical Drugs Supplies.
Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs.
Provides operational input into the development and tracking of SMT goals.

Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
Develops and executes appropriate site and CRO/vendor audit and quality plans.

Identifies areas of best practice and process improvements
Participates in Pharma Development Operations initiatives and programs as assigned.
Maintains oversight and ensures consistency of the operational aspects across studies within a project.

Ensures study adherence to ICH/GCP and SOPs


Requirements:

Skills:
More experienced GSM with 5+ years of study management experience

Education:
Life sciences degree or nursing equivalent and 5-7 years of experience in a clinical research/a healthcare environment.


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
lc_ad

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 3 days ago

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 www.cytomx.com. 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

Compass Consulting Group