Job Description

Work Schedule Standard (Mon-Fri)
Environmental Conditions Office

CDM PM:
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 2,700 clinical trials across 100+ countries in the last 5 years.
Role Overview:
As a Clinical Data Manager Project Manager, you will lead a portfolio of studies or programs, owning functional, administrative, and financial oversight from start?up through close?out. Serving as the primary liaison to clients and cross?functional teams, you will coach and direct CDM staff, manage budgets and resources, forecast and mitigate risks, and ensure delivery to scope, quality, timelines, and cost. You will review and elevate DM deliverables, drive process improvements and training, support bid and client development activities, and mentor teams to consistently achieve inspection?ready outcomes
What You'll Do:

• Provide support and coaching to the DM team to ensure that all tasks are completed accurately, on time and within budget to meet or exceed client
• expectations.
• Act as a primary liaison for project team and client.
• May develop and implement study specific training for DM project staff and performs independent reviews of DM deliverables following CDM guidelines.
• Monitor, evaluate and propose mitigation strategies surrounding risk to deliverables and finances.
• Participate in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required. Additionally, promote repeat business by developing relationships with new and existing clients.
• Perform project forecasting of hours and identification of resource requirements and manage project budgets including identification of out of scope work and participate in the Contract Modification process.
• Participate in the development and implementation of processes, procedures and training for the data management function as directed.
• Mentor junior level staff and peers on all associated tasks within a study or program.
• Independently lead and delegate tasks to ensure timely completion of project activities to project timelines, quality and budget.

Education and Experience Requirements:

• Bachelor's degree or equivalent and relevant formal academic
• Previous experience (Min 6 to 8 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, global SOPs and client expectations
• Ability to use interactive computer programs
• Excellent written/ verbal communication skills with a strong command of English language and grammar; strong organizational and analytical/problem solving skills; strong customer focus and excellent interpersonal skills
• Ability to identify project risks and to effectively evaluate and develop plans to mitigate those risks
• Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
• Ability to act as a study or department expert for DM processes.
• Ability to train and direct a study team, providing leadership and direction to both subordinates and peers
• Ability to forecast project resourcing, project timeline planning and adherence to timelines.
• Ability to supervise and delegate tasks.
• Ability to successfully apply above skills, knowledge and abilities across a portfolio of studies

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 client's 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., CDM PM, Sr CDM PM) or transition into Data Standards/Programming, based on skill, impact, and business need.
Why You'll Want to Join:

• Join our FSP Data Management team and help bring life?changing medicines to patients worldwide. Accelerate your growth with hands?on experience in modern CDM, from EDC and data quality to AI?enabled workflows--building the expertise to lead data?driven 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 90,000 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

Skills Required