Clinical Trial Leader, US Medical Affairs

South San Francisco
California, United States of America


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The Position

Purpose:

 

The Clinical Trial Leader (CTL) will provide support and/or leadership to one or more Study Management Teams (SMTs) and/or Study Review Teams (SRTs), and provide strategic planning and organization to ensure successful study completion. The CTL will maintain full ownership of the USMA portion of a study and ensure the effective and efficient delivery of the operational aspects in accordance with the Medical Plan, The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) standards, Roche Standard Operating Procedures (SOPs), local operating guidelines and local regulatory requirements.

 

The CTL will  also ensure the development and maintenance of productive relationships with our customers.

 

All Roche employees are expected to effectively contribute to cross-functional collaboration and coordination and comply with all laws, regulations, policies & procedures that govern our business.

 

Role Responsibilities/Accountabilities:

 

In this position, you will be primarily accountable for consistently, effectively:

?      Contributing clinical operations expertise into Medical Plans and study design

?      Managing assigned clinical studies operations, and assuming accountability for such, to ensure delivery of operational activities to meet Study Plans outlined in Medical Plans

?      Providing support,  direction and/or leadership to one or more SMTs

?      Providing Contract Research Organization (CRO) and other vendor oversight

?      Ensuring assigned SMTs and vendor partners deliver on commitments to agreed targets

?      Ensuring study adherence to budget, ICH-GCP standards, Genentech/Roche SOPs and other operating guidelines and regulatory requirements

?      Compliantly developing and cultivating productive relationships with external partners/stakeholders

?      Ensuring that risk and quality plans are robust, proactive and implemented for each assigned study

?      Contributing to study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting continuous improvement

?      Driving and making clear decisions in the project team environment

 

 

 

 

In this position, you will be responsible to:

?      Operations:

?      Serve as a member of one or more global cross-functional Study Management Teams (SMTs) and Study Review Teams (SRTs) through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the

Medical Plan

?      Participate 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. Liaise with cross-functional team members including the SMT members to solicit input

?      Draft and implement study plans, including vendor oversight, risk, quality, safety, communication

?      Support EDC and Clinical Trial Management System (CTMS) systems and data maintenance

?      Track budget, timelines, milestones, and critical study activities; identifying issues and proposing potential resolutions

?      Partner closely with Medical colleagues to provide strategic operational input on protocol feasibility

?      Provide input into the study budget and manage assigned vendor budget(s); communicate variances in actual versus forecasted spend in vendor budgets and present an action plan for resolution to the Study Management Team Leader (SMTL)

?      Participate in selection of vendors (participate in the Request for Proposal [RFP] process), in collaboration with the SMTL

?      Utilize outputs from operational analytical tools to enhance and improve study execution

?      Oversee delegated outsourced activities to ensure Contract Research Organization (CRO) and vendor delivery against contracted scope of work.

?      Contribute to study site selection and management

?      Oversee protocol, country, and site feasibility assessments

?      Assist with all activities related to site selection, contracting, set-up and maintenance

?      Partner with Site Contracts on development of site budget template and budget negotiations

?      Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness

?      Coordinate planning and execution of effective investigator meetings. As appropriate/applicable, drive agenda and content for investigator meetings

?      Ensure accuracy and timeliness of CTMS, timeline planning tools and other core systems

?      Ensure study adherence to ICH/GCP and SOPs

 

?      Other:

?      Stay current on relevant therapeutic knowledge and clinical research best practices

?      Participate in the evaluation of standards across one or more SMT(s)/SRT(s) with the objective of enhancing quality, productivity and efficiency

?      Provide support, mentoring and study-specific training to other USMA Clinical Operations team members

?      As appropriate, serve as subject matter expert on task forces, initiatives and various working groups; contributing to USMA and USMA Clinical Operations initiatives

 

 

Skills:

 

?      Proven track record of meeting or exceeding objectives and goals

?      Demonstrable abilities to work more independently (with less guidance and supervision) in strategizing, designing and overseeing local clinical study plans and projects

?      Strong business acumen: knows the industry, key competitors and other marketplace factors/dynamics

?      Good project and process management skills: can prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment of such

?      Good communication & presentation skills: communicates in a timely, thorough and concise manner and is comfortable presenting information to others at varying organizational levels

?      Strong influencing & negotiation skills

?      Strong interpersonal & partnering skills: has proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams

?      Financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources

?      Strong customer orientation/focus

?      Good computer skills, including common desktop programs

?      Business travel, by air or car, may be required for internal and external business meetings

 

 

Background/Experience and Education:

 

?      Bachelors Degree in a medical/science-related discipline

?      Strong knowledge of ICH-GCP and other relevant standards and guidelines

?      Strong knowledge of operational aspects of clinical trial management and the drug development process

?      Knowledge of relevant therapeutic areas is a plus

?      Experienced in managing aspects of one or more global, complex, clinical studies and generally experienced in clinical research/development

?      4 (E3) or 7 (E4) more years’ proven experience in clinical research and development (amount of experience will designate the job family level)

?      Demonstrated experience in at least one therapeutic area relevant to the work of Genentech/Roche

?      Clinical development experience in operational aspects of conducting clinical studies, including: Vendor/CRO management

?      Participating in or leading a Study Management Team

?      Implementing clinical development/medical plans

?      Coordinating study level activities to deliver data for filing or publication purposes

?      Project management experience including implementation of risk management plans and management of complex study budgets and resourcing plans

 

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.


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