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.
Learn more about the general tasks related to this opportunity below, as well as required skills.
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, visitwww.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.
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