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Clinical Trial Leader

Kelly Services

South San Francisco, CA
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Job Details

Job Title Clinical Trial Leader

Jobid US15TPCT_BH1429644

Location: South San Francisco, CA, 94080, USA

Description Kelly Scientific Resources is the world's most recognized brand in Scientific Staffing with more than 100 locations in the North America, Europe and the Pacific Rim. Our scientists contribute to the research and development of products that are used daily in the home, such as medical devices or pharmaceutical products. We employ more than 700 clinical research professionals and 4,500 scientists on an average workday on a temporary, project and full-time basis in a broad spectrum of industries and disciplines. We currently have an exciting opportunity in the San Francisco area as a Clinical Trial Leader.

**Key roles and responsibilities include, but are not limited to:**

+ Serves as a member of one or more global cross-functional Protocol Execution Team(s) (PETs) through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the clinical development plan:
+ Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central / specialty lab, ECG, imaging, and PRO specifications, drug supply and biomarker/ sample management plans, TMF, and CSRs. Liaises with cross-functional team members including the PET members to solicit input.
+ Drafts and implements study plans including; vendor oversight, risk, quality, safety, communication, trial/medical monitoring, TMF.
+ Ensures TMF creation and QC completion.
+ Supports EDC and CTMS systems and data maintenance.
+ Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions.
+ Partners closely with Clinical Science in designing global clinical trial protocols and provides strategic operational input on protocol feasibility.
+ Provides input to the study budget and manages assigned vendor budget(s); communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution to Protocol Execution Team Lead (PETL).
+ Participates in selection of vendors (participates in the Request for Proposal (RFP) process), on a global scale, in collaboration with the PETL.
+ Utilizes outputs from operational analytical tools to enhance and improve study execution.
+ Oversees delegated outsourced activities to ensure CRO and vendor delivery against contracted scope of work.
+ Contributes to global study site selection & management:
+ Conducts global protocol, country, and site feasibility assessments.
+ Assists with all activities related to global site selection, contracting, set-up and maintenance.
+ Contributes to the development and active management of study-specific patient recruitment strategies through participation in enrollment planning workshops.
+ Proactively identifies risks and develops risk mitigation strategies to ensure operational effectiveness.
+ Contributes to the efforts and overall success of the wider gRED Clinical Operations team:
+ Collaborates effectively and participates in the CTL Forum and other departmental meetings.
+ Identifies and synthesizes best practices and process improvements and shares outputs with peers.
+ Serves as subject matter expert for mandatory business initiatives and/or functional initiatives.
+ Coordinates planning and execution of effective investigator meetings. May be accountable for driving agenda and content for investigator meetings.
+ Stays current on relevant therapeutic knowledge and clinical research best practices.
+ Ensures accuracy and timeliness of CTMS, timeline planning tools and other core systems.
+ Ensures study adherence to ICH/GCP and SOPs.
**Key Capabilities**

The capabilities required for this role are for a developing leader which means the candidate demonstrates the ability to manage delegated aspects of the study with minimal direction, is self-aware and takes initiative to fix and learn from mistakes, demonstrates good judgment in seeking guidance and exercises professionalism.

+ Experienced in managing aspects of one or more early development phase (I and II), global, complex, clinical studies and generally experienced in clinical research/development.
+ Highly effective verbal (including oral presentations) and written communication skills in English; effectively delivers key messages; aptitude to independently communicate with teams and stakeholders.
+ Demonstrates an aptitude to distill information from multiple sources to create meaningful insights and induces collaboration and innovative thinking study-wide.
+ Demonstrated experience in at least one therapeutic area.
+ Experience with effective vendor management.
+ Demonstrates an aptitude for strategic thinking skills; manages risks (including risk identification and mitigation); identifies critical path / critical dependencies.
+ Strong customer focus with investigators, functional peers, vendors, country affiliates, etc.
+ Excellent planning and organizational skills.
+ Ability to build trusting and collaborative relationships that promote innovation, knowledge-sharing and adaptation to change.
+ Practices the ability to influence and negotiate to achieve team goals.
+ Consistently supports change in an effort to continue to develop gRED’s dynamic organization.
+ Demonstrates creativity and innovation to support projects and initiatives.
+ Strong technical and analytical skills and ability to manage system data maintenance across multiple systems. Aptitude to interpret outputs from analytical tools to enhance and improve study execution.
+ Self-motivated, achievement-driven and exhibits ability to work with minimal guidance.
**Education / Qualification:**

+ Bachelor’s degree or equivalent required (scientific or healthcare discipline preferred).
+ 5+ years of study management experience in clinical and drug development.
+ Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.
**Other (e.g. Travel):**

+ Willingness to travel domestically and internationally, and work across cultures.
+ Visual acuity and sufficient dexterity to constantly operate a computer and other office productivity machinery (i.e., a calculator, copy machine, and computer printer) in a stationary position.

+ Work on nights or weekends is not typically required, however, interaction on global clinical studies requires flexibility for occasional teleconferences / meetings outside of core working hours.
36 month contract

**If you meet the minimum required skillsets…

Please apply now for immediate consideration!

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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