Country Study Manager W2 ONLY 7432810

South San Francisco, CA

Post Date: 08/18/2017 Job ID: 3108 Industry: Professional Positions
W2 ONLY   12 Month Contract   Position   Purpose:

Provides leadership to one or more Local Study Teams (LSTs) and provides local strategic planning and organization to achieve successful study completion. The CSM maintains full ownership of the affiliate portion of a study and ensures the effective and efficient delivery of country/region operational aspects in accordance with the study development plan and ICH/GCP standards, our client’ s SOPs, local operating guidelines and local regulatory requirements. The CSM also ensure the development and maintenance of productive relationships with our customers.

Main Responsibilities and Accountabilities:

Provides Direction and Leadership to one or more LSTs


Builds effective, high performing LSTs through influence, integrations, motivation and optimization of team performance. Embeds our client’ s values into the team(s) culture and promotes the team spirit.

·         Sets the LST goals and ensures goals are in line with the operational strategy agreed by Clinical and Study Management Teams. Provides coaching to the team to facilitate the setting and achievement of goals

·         Ensures that each team member is aware of his/her specific area of accountability and responsibility within the LST

·         Manages and coaches performance of study team members by setting expectations, supporting team members, monitoring performance, providing feedback and following up, when appropriate to ensure performance is optimized

·         Liaises with other functional groups to ensure the LST(s) members and monitors receive appropriate therapeutic areas and study specific training


Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders, e.g. Pharma Business, GSOM, functional management


Represents the LST(s) at the SMT


Maintains awareness of external clinical research practices to ensure the LST(s) and monitors are aware of the risks, priorities, value and impact of their work and contributions

Establishes Study Timelines, Budget, Resource, Risk and Quality Plans

Provides the GSOM with feedback from an Affiliate perspective into the study synopsis, development of the final protocol, feasibility conduct and all study specific documents and procedures

·         In collaboration with Country Study Specialist (CSS) oversees project, protocol and site feasibility and determines site selection and patient allocation (total and annualized) within the affiliate and the HQ study (GSL and GSOM)

·         In collaboration with CSS analyzes results of project, protocol and site feasibility testing, and provides country feedback or recommendations to SMT

In accordance with the overall project plan, establishes and maintains accurate study level plans in Pharma planning systems (e.g., CTMS, PlanSource, etc.)

·         Develops Affiliate scenario plans that deliver the studies on time, with the most efficient use of budget and resources

·         Develops country/regional level study timelines and ensures that milestones are set and managed for the overall studies delivery in association with the GSOM

·         Develops and manages Affiliate budget/financial plan, and forecasts using appropriate tools, ensures the LST(s) has the appropriate resources to effectively deliver high quality studies on time and within budget

·         Provides input from a country/region perspective into development and implementation of drug management budgeting, resourcing, source document verification, data flow, case report forms, and safety monitoring for the Affiliate via the GSOM

·         Provides input on local requirements for biologic sample plan to the Global Biosample Specialist

·         In collaboration with the GSOM and where necessary, PDG, develops and executes the local implementation of the audit quality and risk management plans identifying critical issues for the Affiliate and ensuring contingencies are established and captured in the study level risk management plan. Ensures that the plans are reviewed and updated over the course of the studies

·         Provides content review and input into the global communications plan

·         Develops local LST communication plan


Is accountable for the development and active management of the study patient recruitment strategies in the affiliate.


Develops Partnership with Business, participates on local life cycle teams, consults local Business Units, and participates in local Business Unit meetings as necessary.


Is accountable for the selection, training and management of external suppliers supporting the Affiliate.

Manages the Deliver of Study Activities in Order to Meet Study Plans
In collaboration with Study Start-­? Up Specialists ensures the timely submission of all regulatory, ethical and administrative submissions and helps to ensure their appropriate approval

·         Design and implement a country level training plan to ensure that team members and investigators receive training on the protocol, ICH/GCP requirements, and our client’ s applicable processes/procedures

·         Ensures protocol adherence and consistency of study processes and procedures across all Affiliate investigational sites

·         Ensures studies in the Affiliate are performed and conducted in compliance with ICH-­? GCP guidelines, our client’ s SOPs, local operating guidelines and all applicable regulatory requirements

·         Ensures patient safety and data quality maintained, and that any concerns are escalated appropriately

·         In collaboration with CCS ensures monitoring reports are timely, reviewed and that appropriate actions is taken on site issues


Ensures that data is delivered in accordance with established dataflow timelines

·         In collaboration with CSS ensures that trial management tracking tools (e.g., CTMS, SDE, Quantum, etc.) and systems are populated and maintained


Develops/maintains investigator relations, builds and maintains a professional relationship between our client and investigator, participating in Affiliate Investigator Meetings as necessary

·         Leads and or organizes (or assists in organizing) and/or participates in local or regional meetings and training sessions (i.e. LST meetings, Investigator Meetings, Monitors Workshops and CRO training)


Implements the country level recruitment plan


Monitors progress against LST goals and take appropriate action to ensure goals are met and issues are communicated with the appropriate persons or teams

·         Chairs LST meetings, ensuring appropriate follow up is taken on action points

·         Provides the SMT (via the GSOM) with regular status updates with regard to Affiliate recruitment and investigational sites

·         Communicates regularly on country/region study(s) status and escalates unresolved issues appropriately to the Country Head, Line Manager or a Team Leader


Oversees the management of the local affiliate studies budget

Identified Areas of Best Practice and Process Improvements

Leads the evaluation of standards across one or more LST(s) with the objective of enhancing quality, productivity and efficiency

·         Proactively incorporates learning and recommendations from study debriefs and best practices

·         Maintains oversight and ensures consistency across studies within a project at the affiliate level


Contributes to activities to improve and maintain the quality and effectiveness of processes and activities within the function


Makes an active contribution to therapeutic area strategy teams (e.g., Oncology Franchise Network) ensuring knowledge shared locally and globally

Takes ownership for own development Qualifications

·         University degree or equivalent in a medical/science related field and or 5 years proven

experience in Clinical Research/Development or related industry


Skills, Experience and Competencies:

?      Demonstrated ability to interact with different professional levels of the research community

?      Strong leadership skills developed through leading multi-­? functional matrix study teams through all stages of clinical studies

?      Proven clinical development experience on the operational aspects of conducting clinical studies including vendor/CRO management leading/working as part of a development team, implementing clinical development plans and coordinating study level activities to deliver data for filing or publication purposes including interaction with local business units

?      Experience in project management including implementation of risk management plans and management of complex study budgets and resourcing plans

?      Experience influencing and negotiating at all level to achieve team delivery

?      Able to communicate clearly and accurately in both written and spoken English

?      Excellent written and verbal communication skills demonstrated by an ability to present clear messages from complex information/data to all levels in the organization

?      Demonstrated ability to prioritize and manage multiple tasks

?      Self-­? motivated and achievement driven

?      Strong computer skills – experience using various computer applications including spreadsheets, email, word processing software



·         International travel required


Calley Molina

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