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Assoc Dir, FSP 360 Clinical Operations
9-13 years
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Assoc Dir, FSP 360 Clinical Operations
Syneos Health
posted 4d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
JOB SUMMARY
Provides leadership, direction, and management to FSP 360 functional teams. Provides training,
consultation and oversees quality related to operating activities of assigned staff to ensure project
deliverables are met. May liaise with other departments or business units to optimize resources as well as
to establish harmonized clinical operations practices, processes, and tools. Contributes to operational
initiatives. Acts as an SME where country/region/functional knowledge is key. May act as a regional
operational lead.
JOB RESPONSIBILITIES
Overall, the role will be responsible for three primary performance areas:
(1) Customer Delivery and Success
Develops and fosters strong, collaborative relationships with customers and escalates more
serious issues as required. Solicits feedback from customer PoC (s) for continuous improvement
of service delivery and to strengthen customer relationships.
Responsible for delivery and compliance with agreed-upon KPIs, as well as analyzing
performance and quality metrics to assure BU achievement of regional productivity and
compliance metrics; develops and executes mitigation and remediation plans for non-compliance
as needed. Expected to address improvement initiatives as identified.
Responsible for managing headcount and reviewing workloads for all staff in the reporting chain.
Oversees resource availability for assigned staff, country, or region, ensuring projects are
adequately staffed and staffing needs are promptly identified. Resolves potential resourcing
conflicts to facilitate mutually beneficial resolutions. Collaborates with local Talent Acquisition
(TA) teams and identifies future customer resourcing needs.
Proactively communicates and manages customer issues through assigned escalation channels.
Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs)
and compliance with federal and local guidelines and ICH GCPs. Ensures all staff follow the
required training and complete the required documentation. Provides regular compliance updates
to management accordingly.
Conducts oversight visits as required for Clinical Research Associates.
Responsible for all system updates, and compliance with systems and relevant procedure and
practices applicable to the customer and Syneos Health processes.
Provides leadership, direction, and management to FSP 360 functional teams. Provides training,
consultation and oversees quality related to operating activities of assigned staff to ensure project
deliverables are met. May liaise with other departments or business units to optimize resources as well as
to establish harmonized clinical operations practices, processes, and tools. Contributes to operational
initiatives. Acts as an SME where country/region/functional knowledge is key. May act as a regional
operational lead.
JOB RESPONSIBILITIES
Overall, the role will be responsible for three primary performance areas:
(1) Customer Delivery and Success
Develops and fosters strong, collaborative relationships with customers and escalates more
serious issues as required. Solicits feedback from customer PoC (s) for continuous improvement
of service delivery and to strengthen customer relationships.
Responsible for delivery and compliance with agreed-upon KPIs, as well as analyzing
performance and quality metrics to assure BU achievement of regional productivity and
compliance metrics; develops and executes mitigation and remediation plans for non-compliance
as needed. Expected to address improvement initiatives as identified.
Responsible for managing headcount and reviewing workloads for all staff in the reporting chain.
Oversees resource availability for assigned staff, country, or region, ensuring projects are
adequately staffed and staffing needs are promptly identified. Resolves potential resourcing
conflicts to facilitate mutually beneficial resolutions. Collaborates with local Talent Acquisition
(TA) teams and identifies future customer resourcing needs.
Proactively communicates and manages customer issues through assigned escalation channels.
Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs)
and compliance with federal and local guidelines and ICH GCPs. Ensures all staff follow the
required training and complete the required documentation. Provides regular compliance updates
to management accordingly.
Conducts oversight visits as required for Clinical Research Associates.
Responsible for all system updates, and compliance with systems and relevant procedure and
practices applicable to the customer and Syneos Health processes.
(2) Business Impact
Responsible for partnering with internal and external stakeholders to drive and oversee customer
growth strategies. May provide support to facilitate new project awards during the proposals and
Bid Defense process, providing expert functional guidance where required. May participate in
marketing activities, customer presentations and proposal development.
Responsible for knowledge sharing across the business unit to disseminate best practices and
lessons learned in support of the overall FSP 360 operating model. Makes informed and datadriven
decisions that result in positive impact on overall business unit performance.
Responsible for delivering BU revenue targets by supporting the assessment of overall program
customer delivery and the development of program/regional staff plan.
May serve as a Company representative at professional meetings or seminars.
(3) People Leadership
Responsible for active management of team members performance through the established
Syneos Health process; at an individual contributor level (M23+) and manager level. Act as a
local SME for people related queries.
Verifies that team members adhere to training guidelines, maintain their training records and
individual and corporate training needs are identified and addressed.
Provides administrative oversight (for example, HR processes, timecards, expense reports).
Supports team members professional development through coaching, providing opportunities to
increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
Proactively works to ensure team members engagement, retention and turnover rates remain
within expected levels.
Demonstrates commitment to diversity, equity, and inclusion through continuous development of
all staff, modeling inclusive behaviors and proactively managing bias.
Responsible for partnering with internal and external stakeholders to drive and oversee customer
growth strategies. May provide support to facilitate new project awards during the proposals and
Bid Defense process, providing expert functional guidance where required. May participate in
marketing activities, customer presentations and proposal development.
Responsible for knowledge sharing across the business unit to disseminate best practices and
lessons learned in support of the overall FSP 360 operating model. Makes informed and datadriven
decisions that result in positive impact on overall business unit performance.
Responsible for delivering BU revenue targets by supporting the assessment of overall program
customer delivery and the development of program/regional staff plan.
May serve as a Company representative at professional meetings or seminars.
(3) People Leadership
Responsible for active management of team members performance through the established
Syneos Health process; at an individual contributor level (M23+) and manager level. Act as a
local SME for people related queries.
Verifies that team members adhere to training guidelines, maintain their training records and
individual and corporate training needs are identified and addressed.
Provides administrative oversight (for example, HR processes, timecards, expense reports).
Supports team members professional development through coaching, providing opportunities to
increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
Proactively works to ensure team members engagement, retention and turnover rates remain
within expected levels.
Demonstrates commitment to diversity, equity, and inclusion through continuous development of
all staff, modeling inclusive behaviors and proactively managing bias.
Qualifications
Bachelor s degree in life sciences, nursing degree, or equivalent related experience, plus
extensive clinical research experience in a contract research organization, pharmaceutical or
Biotechnology Company, including some time in a leadership capacity or equivalent combination
of education, training and experience is required.
Knowledge of GCP/ICH guidelines and other applicable regulatory requirement.
Excellent communication, presentation, interpersonal skills; both written and spoken, with an
ability to inform, influence, convince, and persuade.
Strong time management, technical and organizational skills. Ability to work independently and
within a team environment.
Creative problem solver who is self-motivated, flexible, open to change, collaborative, and
possesses a customer-centric mindset.
Demonstrate strong leadership skills, including ability to set direction, mentor and motivate others
to achieve departmental goals.
Demonstrate understanding of the workflow process, roles, and responsibilities of multiple
functional areas.
Ability to travel as necessary; up to 25%.
extensive clinical research experience in a contract research organization, pharmaceutical or
Biotechnology Company, including some time in a leadership capacity or equivalent combination
of education, training and experience is required.
Knowledge of GCP/ICH guidelines and other applicable regulatory requirement.
Excellent communication, presentation, interpersonal skills; both written and spoken, with an
ability to inform, influence, convince, and persuade.
Strong time management, technical and organizational skills. Ability to work independently and
within a team environment.
Creative problem solver who is self-motivated, flexible, open to change, collaborative, and
possesses a customer-centric mindset.
Demonstrate strong leadership skills, including ability to set direction, mentor and motivate others
to achieve departmental goals.
Demonstrate understanding of the workflow process, roles, and responsibilities of multiple
functional areas.
Ability to travel as necessary; up to 25%.
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
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