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18 days old

Director Clinical Research

Kelly Services
San Francisco, CA 94103
Kelly is hiring for a **Director Clinical Research** position with one of our clients in **San Francisco, CA.**


+ 12 months contract (May be extended or converted)

+ $100/hr


Job Description:


+ Lead and coordinate a team of experts in accordance with the study team operating model and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of timelines, budget and quality standards

+ Contribute to vendor/external service provider selection activities at the study level, including bid defense, and lead operational oversight

+ Collaborate with other functions to establish strategies and identify common practices aimed at increasing efficiency of global study teams

+ Lead and facilitate communication across functions and provide guidance to study team members as needed

+ For outsourced studies, be the primary point of contact for the CRO Study Manager to ensure study delivery, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, following relevant SOPs and guidelines (e.g. description of services and transfer of obligations)

+ Provide operational expertise into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)

+ Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities

+ Develop and maintain relevant study plans including required input into study level quality and risk management planning with risk response strategies and clear issue resolution pathways

+ Oversee study level performance against agreed upon plans, timelines and key performance indicators (quality and operational) by using company tracking systems and project timelines, while communicating any risks to timelines and/or quality, along with proposed mitigations

+ Identify and report quality issues that have occurred and collaborate with all functions as necessary to overcome barriers and achieve desired outcomes

+ Oversee Trial Master File (TMF) completion including ensuring the TMF plan and Expected Document List are in place and that QC activities are performed on an ongoing basis

+ Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, budget attestations, Clinical Trial Transparency)

+ Responsible for study budget re-forecasting following initial budget estimate provided by the Clinical Program Team and accountable for budget management through the study lifecycle

+ Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines

+ Support professional development of team by providing regular feedback on individual performance

+ Provide guidance, training, expertise, mentoring and support to less experienced study management colleagues

+ Leads non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager


Qualifications and Education Requirements:


+ University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research

+ Previous global project management experience and training

+ At least 7 years of clinical trial experience

+ At least 3 years of experience in global study leadership and team leadership

+ Oncology experience required, haematology preferred.

+ Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery; start up, maintenance and close out.

+ Thorough understanding of the cross-functional clinical trial process e.g. Data flow


Preferred Skills:


+ Strong strategic and critical thinking abilities

+ Proven skillset and abilities to solve complex problems and make strong decisions

+ Strong abilities in establishing and maintaining effective working relationships with strong conflict management skills

+ Demonstrated abilities in mentoring

+ Excellent communication and interpersonal skills

+ Ability to lead multiple challenging priorities

+ Experience in external provider oversight and management


\#P2


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-08-01 Expires: 2022-09-10

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Director Clinical Research

Kelly Services
San Francisco, CA 94103

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