SDM Clinical Data Team lead

As a Clinical Data Team Lead you will serve as the lead data manager for one or more studies owningendtoenddata management from study setup through database lock. You will direct CDM activities apply protocol requirements to team workflowsmaintainDM documentation and ensure deliverables meet quality timeline and regulatory standards. Acting as the primary liaison to project leadership and clients you willmonitorstudy metrics produce status reports forecast resourcesidentifyoutofscopework and support bid activities as needed. You will also train and mentor team members and contribute to the administrative andfinancial managementof assigned projects.

WhatYoullDo:

Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks.
Acts as a liaison to the Project Lead and/or client asandcommunicateswith managementregardingall data management (DM) activities within their studies.
Develops andmaintainsdata management project documentation files; performs independent reviews of data management deliverables following documented CDM guidelines.
Develops and delivers study specific training for DM project staff.
Produces project-specific status reports for management ProjectLeadand/or clients on a regular basis. Monitors study metrics.
Mayparticipatein business development activities byassistingwith bid preparation and/orrepresentingdata management at bid defense meetings where.
Assistswith project forecasting of hours and identification of resource requirements andidentifiespotential out of scope activities to Project Lead and management andassistswith the Contract Modification process.
Mentors junior level staff on all associated tasks within a study.
Assistswith the administrative andfinancial managementofallocatedprojects. Performs all assigned data management activities independently and efficiently with attention to quality.

Education and Experience Requirements:

• Bachelors degree or equivalent and relevant formal academic

• Previousexperience (Min4to5.6Years) that provides the knowledge skills and abilities to perform the job

• Should have experience in RAVE / Veeva EDC

KnowledgeSkillsand Abilities:

Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines SOPs and client expectations
Ability to use interactive computer programs
Good written/ verbal communication skills with a strong command of English language and grammar; good organizational analytical/problem solving skills and attention to detail
Ability to work productively with minimal supervision
Ability to maintain a high degree of confidentiality with clinical data and clients proprietary data
Strong customer focus and excellent interpersonal skills
Proven flexibility and adaptability
Ability to work in a team environment and independently as needed
Ability to train and direct study team
Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands

Your Career Growth:

Our FSP model supports continuous learning and career development by offering employees tailored learning pathways stretch assignments and mentorship this allows FSP professionals to expand their horizons. This role opens multiple career paths. You could progress along the Clinical Data Management track (e.g. Senior CDM CDTL CDM PM) or transition into Data Standards/Programming based on skill impact and businessneed.

WhyYoullWant to Join:

• Join our FSP Data Management team and help bringlifechangingmedicines to patients worldwide. Accelerate your growth withhandsonexperience in modern CDM from EDC and data quality toAIenabledworkflowsbuilding theexpertiseto leaddatadrivenstudy delivery in a rapidly evolving clinical landscape

• Global exposure:

Work on international clinical studies across phases and therapeutic areaspartnerwith global teams CROs vendors and country operations.

• End-to-end ownership:

Contribute to every stage of study delivery from set-up to close-out.

• Analytical & project skills: