Associate Clinical Data Manager - Early Phase Trials

Fortrea; Leeds; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

Fortrea, a leading global contract research organization, is seeking an Associate Clinical Data Manager for early phase studies. This remote or hybrid role offers a chance to lead data management projects while ensuring compliance with industry standards. Join Fortrea to make a significant impact in the clinical research field while enjoying competitive compensation and a supportive work environment.

Benefits

Highly competitive compensation packages

Flexible working hours

Thorough onboarding program

Support from personal mentor

Work-life balance

Qualifications

• Experience in clinical data management as a Lead DM or similar role.
• Knowledge of clinical trial processes and biometrics.
• In-depth understanding of regulatory obligations in CRO industry.

Responsibilities

• Lead operations team and develop project documentation.
• Assist in creating study milestone timelines.
• Proactive risk management and issue resolution.

Skills

Excellent oral and written communication skills

Problem-solving

Risk management

Knowledge of CDASH and SDTM standards

Education

University/college degree in life sciences or pharmacy

Certification in allied health profession

Job description

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Associate Clinical Data Manager - Early Phase - remote or hybrid

Do you have experience leading data management activities across early phase studies? Are you looking for a new challenge in an environment where you be closely supported by your Manager, peers and Senior Leaders in your team? Perhaps you are seeking to gain further experience in new therapeutic areas.

Join our growing team and discover your extraordinary potential by working as an Associate Clinical Data Manager within our Early Phase team.

What you can expect from us

• Office based or home based anywhere in the listed countries
• Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
• Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.
• A genuine work life balance
• Flexibility in working hours
• A thorough onboarding with support from your personal mentor
• A permanent employment contract with Fortrea and a rewarding career progression

Your responsibilities

• Assist and lead operations team alongside Senior CDM, develop project documentation, system setup, data validation processes and procedures assigned to junior staff.
• Work with Senior CDM to build study milestone timelines and be able to read and follow study timelines for on-time deliverables.
• Assist or lead internal and external DM meetings.
• Responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology
• Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.
• Specialist in TA specific data capture and standards, conducts lessons learned and disseminate across the organization as appropriate
• May act as a team leaders or mentor Clinical Data Management colleagues and any stakeholder with operational processes used in studies and projects.
• Demonstrates willingness to take on and lead any project level activity consistent with current or experience in support of study delivery

Your profile

• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• Additional relevant work experience will be considered in lieu of formal qualifications.
• Experience in clinical data management as a Lead DM or Senior CDA or similar within early phase trials (phase I-IIa) at CRO/pharma level.
• Excellent oral and written communication and presentation skills.
• In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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