Clin Data Team Lead

Work Schedule

Environmental Conditions

Job Description

CDTL:

Join Us as a Clinical Data Associate I Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 Bio-techs spanning 2700 clinical trials across 100 countries in the last 5 years.

Role Overview:

As a Clinical Data Team Lead you will serve as the lead data manager for one or more studies owning endtoend data management from study setup through database lock. You will direct CDM activities apply protocol requirements to team workflows maintain DM documentation and ensure deliverables meet quality timeline and regulatory standards. Acting as the primary liaison to project leadership and clients you will monitor study metrics produce status reports forecast resources identify outofscope work and support bid activities as needed. You will also train and mentor team members and contribute to the administrative and financial management of assigned projects.

What Youll Do:

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 as required and communicates with management regarding all data management (DM) activities within their studies.
Develops and maintains data 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 Project Lead and/or clients on a regular basis. Monitors study metrics.
May participate in business development activities by assisting with bid preparation and/or representing data management at bid defense meetings where required.
Assists with project forecasting of hours and identification of resource requirements and identifies potential out of scope activities to Project Lead and management and assists with the Contract Modification process.
Mentors junior level staff on all associated tasks within a study.
Assists with the administrative and financial management of allocated projects. 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
• Previous experience (Min 4 to 5.6 Years) that provides the knowledge skills and abilities to perform the job
• Should have experience in RAVE / Veeva EDC

Knowledge Skills and 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:

We are hiring a team in India to support our FSP client - a large globally recognized biopharmaceutical organization with a strong legacy in specialty medicines vaccines and scientific innovation. This sponsor is known for its commitment to patients global research and development and long-term investment in science. As a client dedicated FSP employee you will collaborate with our clients global data science team contribute to complex and high visibility initiatives and work within a mature FSP delivery model focused on quality and partnership

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 business need.

Why Youll Want to Join:

• Join our FSP Data Management team and help bring lifechanging medicines to patients worldwide. Accelerate your growth with handson experience in modern CDM from EDC and data quality to AIenabled workflowsbuilding the expertise to lead datadriven study delivery in a rapidly evolving clinical landscape
• Global exposure:

Work on international clinical studies across phases and therapeutic areas partner with 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:

Strengthen global project management financial tracking data analysis and risk management abilities. Learn new clinical trial technologies like AI platforms to conduct a global clinical trial

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world healthier cleaner and safer. Whether our customers are accelerating life sciences research solving sophisticated analytical challenges improving patient diagnostics and therapies or making their laboratory work more efficient we are here to support them. Our distributed team of more than 90000 colleagues delivers an outstanding combination of innovative technologies purchasing convenience and pharmaceutical services through our industry-leading brands including Thermo Scientific Applied Biosystems Invitrogen Fisher Scientific Unity Lab Services and Patheon. For more information please visit. Thermo Fisher Scientific is a Equal employment opportunity