Work Schedule

Environmental Conditions

Job Description

The Clinical Trial Manager (CTM) operates crossfunctionally with global accountability for operational deliverables of clinical studies from Final Protocol Concept Sheet to Clinical Study Report (CSR) and applicable results disclosure. The CTM provides operational expertise and crossfunctional management that enables the delivery of assigned trials within quality standards agreed upon timelines and budget and in alignment with applicable SOPs and regulatory requirements.

The CTM is assigned a subset of clinical trial management responsibilities under the guidance and supervision of a CTL/CTM who functions as CTT Lead. The CTM may lead the crossfunctional Clinical Trial Team (CTT) for trials with lower complexity in partnership with the Lead Trial Physician. The CTM manages operational planning global coordination and implementation of assigned studies. The CTM establishes and maintains timelines & budget conducts oversight of external partners and oversees risk management and issue resolution contingency planning and decisionmaking. The CTM serves as the Operational Voice for assigned studies both internally and externally.

Successful candidates have experience managing global clinical trial operations CRO oversight feasibility startup and study closure. They lead with humility and partner effectively to deliver with excellence.

ROLES AND RESPONSIBILITIES

The CTM is responsible for managing crossfunctional of assigned global clinical trial(s) from preparation until closure. Responsibilities include:

• If applicable establish and lead the crossfunctional CTT in partnership with the Lead Trial Physician. Work with functional leaders to assign CTT representatives from involved functional areas.
• Ensure clinical trials are executed according to protocol requirements trial plans OGSM procedures ICHGCP and other applicable regulations. Communicate in a transparent clear way and collaborate with CTT members & external partners to achieve clinical trial objectives.
• Oversee crossfunctional planning track study progress and proactively manage completion of trial deliverables and milestones.
• Responsible for leading guiding and overseeing CROs and other vendors to ensure contractual obligations are met according to plan and metrics.
• Manage CTT risk identification & mitigations suggest and collaborate on solutions manage contingency planning and oversee implementation. Manage the implementation of corrective and preventative actions as needed. Maintain awareness of risks or issues that could have crossindication crossfranchise or crossasset impact and escalate to the (Franchise) CODL Head of Trial Operations and/or Senior Management as needed.
• Contribute to the evaluation selection and contracting of CROs and vendors. Ensure scope of work aligns with protocol requirements and established budget and timelines. Oversee contract management and ensure services are delivered per contract. Ensure accurate trial budget management timely management of scope changes and budget reconciliations.
• Ensure CTT members including CRO and vendor teams receive appropriate trialspecific training for their function. Oversee setup coordination and conduct of Investigator Meetings.
• Develop and/or contribute to trialrelated materials such as the clinical protocol study training materials pharmacy manual clinical monitoring plans data management plan eCRF and associated completion guidelines patient information and informed consent site instructions for specimen collection patient recruitment and retention materials etc.
• Act with the mindset of reducing patient & site burden throughout the trial.
• Ensure vendor systems and processes are configured according to protocol requirements & applicable regulations and implemented within established timelines. Contribute to the development and approval of project specifications user acceptance testing implementation and change management.
• Oversee the country and site feasibility process ensure crossfunctional alignment on regional footprint.
• Ensure timely availability of investigational product on site and ensure clinical site accountability records are in place and maintained.
• Perform site oversight visits according to plan. Review monitoring visit reports protocol deviations and data listings to ensure reliable quality data are delivered. Monitor data quality completeness and timeliness. Proactively identify and manage resolution of issues/concerns.
• Partner with Site & Patient Engagement CRO and other vendors on recruitment & retention tactics that engage patients & sites and foster positive experiences. Ensure supportive relationships with clinical sites & trial personnel. Oversee and track patient recruitment.
• Ensure timely collection documentation and reporting of adverse events (AEs) and serious adverse events (SAEs) and collaborate in the submission of reports to regulatory authorities.
• Ensure the Trial Master File (TMF) is maintained and up to date.
• Ensure the CTT CRO and other vendors operate in a constant state of inspection readiness. Collaborate with Quality to ensure quality oversight of assigned trials utilizing available tools. Provides support during audits & inspections for assigned trials.

The CTM will participate in activities other than trialspecific which include but are not limited to:

• Provide feedback on the performance of crossfunctional CTT members. Assist with onboarding new CTMs.
• Embrace innovation. Recognize nonvalueadded activities and propose opportunities for improvement.
• Share best practices & learnings.
• Provide input to procedures SOPs WIs and related documents.
• Contribute to process initiatives within Trial Operations. Contribute to crossfunctional improvement workstreams.

SKILLS AND COMPETENCIES

• Leadership qualities and ability to establish good and effective internal and external working relationships and communication. Good interpersonal skills.
• Good organizational skills to manage multiple varied tasks and prioritize workload.
• Problemsolving skills with ability to identify and resolve issues identify and mitigate risks. Able to maintain a holistic crossfunctional view while diving into details as needed.
• Good written and verbal communication skills acting globally in a culturally diverse dynamic team.
• Knowledge of ICHGCP and other applicable regulations to successfully execute clinical trials.
• Experience with tools and systems for managing clinical studies (MS Project CTMS TMF IWRS eCOA eCRF databases etc).

EDUCATION EXPERIENCE AND QUALIFICATIONS

• Bachelors degree or University degree medical or paramedical (Biology Biomedical Sciences Pharmacy Veterinary etc. or equivalent by experience.
• Minimum of 5 years of experience in Clinical Operations including clinical trial management.
• Biotech experience is a plus.
• Rare disease Autoimmune and/or oncology clinical trial background is a plus.