Country Studies Manager IV
620 E Grand Ave., SSF45 South San Francisco, CA 94080
Bayside Solutions is seeking a Country Studies Manager IV to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Country Studies Manager IV
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Provides direction and leadership to one or more LSTs
- Build effective, high performing LSTs through influence, integrations, motivation and optimization of team performance
- Embeds the client values into the team(s) culture and promotes the team spirit
- Set the LST goals and ensure goals are in line with the operational strategy agreed by management teams.
- Provides coaching to the team to facilitate the setting and achievement of goals
- Ensure that each team member is aware of his/her specific area of accountability and responsibility within the LST
- Manage and coach 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
- Develop and maintain effective working relationships with key stakeholders, e.g. Pharma Business and GSOM
- Represent the LST(s) at the SMT
- Maintain 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
- Establish Study Timelines, Budget, Resource, Risk and Quality Plans
- Provide 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) oversee 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 analyze results of project, protocol and site feasibility testing, and provide country feedback or recommendations to SMT
- In accordance with the overall project plan, establish and maintain accurate study level plans in Pharma planning systems (e.g., CTMS, PlanSource, etc.)
- Develop Affiliate scenario plans that deliver the studies on time, with the most efficient use of budget and resources
- Develop country/regional level study timelines and ensures that milestones are set and managed for the overall studies delivery in association with the GSOM
- Develop and manage 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
- Provide 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
- Provide 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
- Provide content review and input into the global communications plan
- Develop local LST communication plan
- Is accountable for the development and active management of the study patient recruitment strategies in the affiliate.
- Develop partnership with business, participates on local life cycle teams, consults local Business Units, and participates in local Business Unit meetings as necessary.
- Accountable for the selection, training and management of external suppliers supporting the Affiliate.
- Manage the Delivery 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 applicable client processes/procedures
- Ensure protocol adherence and consistency of study processes and procedures across all Affiliate investigational sites
- Ensure studies in the Affiliate are performed and conducted in compliance with ICH- GCP guidelines, SOPs, local operating guidelines and all applicable regulatory requirements
- Ensure 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
- Ensure 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
- Develop/maintain investigator relations, builds and maintains a professional relationship between client and investigator, participating in Affiliate Investigator Meetings as necessary
- Lead and 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)
- Implement the country level recruitment plan
- Monitor progress against LST goals and take appropriate action to ensure goals are met and issues are communicated with the appropriate persons or teams
- Chair 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
- Communicate regularly on country/region study(s) status and escalates unresolved issues appropriately to the Country Head, Line Manager or a Team Leader
- Oversee the management of the local affiliate studies budget
- Identify Areas of Best Practice and Process Improvements
- Lead 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
- Maintain oversight and ensures consistency across studies within a project at the affiliate level
- Contribute to activities to improve and maintain the quality and effectiveness of processes and activities within the function
- Make an active contribution to therapeutic area strategy teams (e.g., Oncology Franchise Network) ensuring knowledge shared locally and globally
- Take ownership for own development
Summary of Qualifications:
- University degree or equivalent in a medical/science related field and or 5 years proven experience in Clinical Research/Development or related industry
- 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