Cdm PM

Work Schedule

Environmental Conditions

Job Description

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 2700 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 startup through closeout. Serving as the primary liaison to clients and crossfunctional 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 inspectionready outcomes

What Youll 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:

• Bachelors 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 clients 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 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. CDM PM Sr 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