Study Operations Manager Clinical Trial Manager - FSP

Key Accountabilities (may include but not limited to the following):

Study Management Oversight:

Supports Global Study Managers (GSMs) other SOMs and the larger study management delivery of the study by leading specific parts of the project driving specific countries executing tasks of moderate complexity and developing solutions to problems as needed to support deliverables

Serves as leader of the local study team (core members ad hoc members and other key stakeholders as on one or more studies

Oversees the preferred Contract Research Organization pCRO and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan and manages and maintains accurate country level plans (e.g. timelines budget risk and quality plans)

May manage the study start up process in countries assigned where the Start Up Project Manager (SUPM) is not assigned and/or oversee the pCRO responsible for these activities as applicable

Liaises with SCP Lead SCP Site Activation Partners (SAPs) and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs)

Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to GSM during planning

Collaborates with accountable roles to identify and manage deviations and risks in study startup and and implements mitigation strategies as . Accountable for resolution of site activation escalations to study teams including offering options for mitigation

May be responsible and accountable for as designated by the GSM:

o Regional country and study level implementation of startup and site activation plans (through SUPM or pCRO if assigned)

o Regional country and study level recruitment strategy o Support of the development of study level plans

o Communication with the local team and internal stakeholders and pCRO as applicable to ensure efficient and timely study delivery of the agreed plans

o Study and/or country vendor management and oversight including follow up and coordination of vendor deliverables

o Assurance of the follow up and coordination of regional and site quality events protocol deviations data issues metrics review site issues and risks audit responses etc.

Study Management Operations:

May help guide the study management strategy by contributing local intelligence and providing accurate updates on delegated tasks to support establishment of critical path activities and risks

May independently take on activities with instruction provided as needed

Through the SCP CTM or pCRO supports the country and investigator outreach process site identification and feasibility ensuring countries and sites can meet all study protocol requirements

Ensures compliance to relevant global and local internal and external requirements and regulations

Ensures timely communication bidirectionally between the global and local study team. Provides protocol level guidance and support to responsible local study team members as applicable

Follows up on region and country level issue status to ensure resolution

Identifies country level trends to improve deliverables processes as needed

Ensures audit and inspection readiness during start up and conduct

Manages applicable quality events with pCRO and local team as

Drives and ensures delivery of data cleaning deliverables for pCRO and sites as applicable

Reviews PreTrial Assessment and Site Initiation Visit reports completed by SCPs

Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level consistent with global plan and local targets

Drives pCRO and/or applicable internal study team members to ensure Trial Master File (TMF) set up meets study requirements and maintains oversight of TMF completeness

Ensures pCRO and/or applicable internal study team members maintain appropriate level Investigational Product (IP) equipment and ancillary supplies management including import/export license management with the support of Clinical Trial Assistants (CTAs) and other roles as

Supports identification contract development and management of local vendors or facilities as per protocol

May lead and guide the closing out of one or more studies of low complexity post database lock

Provides Investigator Meeting (IM) support and management including conducting presentations as appropriate

Provides country level documents to TMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions

Provides support to ECs Regulatory Authorities (RAs) and other relevant (e.g. radiation biobank) submissions and deficiency and query responses for initial and subsequent Clinical Trial Application submissions within required timelines

Ensures the operational delivery of responsible tasks in accordance with the appropriate quality standards including ICH GCP standards SOPs local operating guidelines and local regulatory requirements as applicable

Subject Matter Expertise:

Acts as the point of contact for all study level questions for the local study team ensuring resolution at lowest possible level and when needed liaising with and escalating to appropriate global roles and teams

May lead operational effectiveness initiatives at country or regional level

Utilizes roles in country such as Lead SCP and expert roles such as Contracts Leads and SAPs to provide the global teams with local intelligence and operational nuances to be considered

Provides input on country level per subject costs local vendor costs and other fees where applicable

Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan and Study Monitoring Plan and ensures Trial Master File (TMF) completeness and oversight of all relevant compliance activities for allocated studies

Supports implementation of clients site technology experience systems

Supports implementation of new tools and technologies (e.g. eConsent eISF remote source access remote source data verification/review (SDV/SDR) iConnect implementation of protocol required decentralized trial options)

Skills:

Expertise in the use of study and site dashboards and reporting tools

Detail oriented and possesses technical expertise

Ability to manage moderately complex processes

Risk identification and mitigation strategic planning and critical path analysis skills

Analytical and problem solving skills

Ability to adapt to changing technologies and processes work independently and exercise own judgement

Supportive of an environment where innovation is standard including developing ideas and taking appropriate risks to advance innovative processes

Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of theorganization

Ability to operate in a matrix environment

Fluency in written and spoken English

Ability to work outside of core business hours as required to support global trials or initiatives

Ability to travel as including Investigator Meetings vendor kick off and reset meetings and client internal global or department level meetings

Knowledge and Experience:

Comprehensive knowledge of own discipline with good knowledge of other disciplines to ensure that the study can meet its goals and to serve as a resource for others

Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team

Working knowledge of Good Clinical Practice clinical and regulatory operations and environment in countries under responsibility

Demonstrated clinical research experience and/or study management/startup project manager experience

Demonstrated experience in managing country level operational activities and/or vendors Experience in study and quality management

Knowledge of clinical trial methodology

Experience working in a matrix management environment

Relevant operational clinical trial management experience

o See below Education section for minimum requirements

Education & Experience (Required):

Bachelors of Science or Bachelors of Arts degree with a minimum 5 years of relevant operational clinical trial management experience

Masters of Science or Masters of Business Administration degree with a minimum 3 years of relevant operational clinical trial management experience