Job Highlights
Not Disclosed
Remote Job
Mid-Senior level
Posted 1 year ago
Job details
Peachtree BioResearch Solutions is a specialized full-service CRO that "thinks like a sponsor". Formed almost 15 years ago by a leadership team experienced in buying CRO service while at a global pharma, our operational teams are highly experienced and bring valuable insight for our small sponsor clients - no matter their budget. We do this by investing in people who thrive in an environment where their experience and insight can be leveraged beyond their main functional area. This is a great environment for people who want to do more.
Summary:
Peachtree BioResearch Solutions is looking to add a Principal Clinical Data Manager to our team. This person will report to the Director, Clinical Data Management. This a fully remote position open to candidates in the United States. The selected candidate will be responsible for activities associated with the acquisition, documentation, review, cleaning, and processing of clinical data, collected for investigational and marketed drugs, in clinical trials.
What You'll Do:
The Principal Clinical Data Manager (CDM) will have responsibilities that include, but are not limited to:
Summary:
Peachtree BioResearch Solutions is looking to add a Principal Clinical Data Manager to our team. This person will report to the Director, Clinical Data Management. This a fully remote position open to candidates in the United States. The selected candidate will be responsible for activities associated with the acquisition, documentation, review, cleaning, and processing of clinical data, collected for investigational and marketed drugs, in clinical trials.
What You'll Do:
The Principal Clinical Data Manager (CDM) will have responsibilities that include, but are not limited to:
- Performing/managing the responsibilities associated with the acquisition, documentation, review, cleaning, and processing of clinical data collected for marketed and investigational drugs, in clinical trials. As a member of the clinical study team, relay information regarding data management status, knowledge regarding area of discipline, and timelines affecting Data Management deliverables.
- Ensuring the accuracy and consistency of Case Report Forms and databases designed according to Sponsor specifications, and Clinical Protocol.
- Creating the Data Management Plan, Edit Check Specifications, and Data Management Report while ensuring consistency with the Clinical Trial Protocol and follow internal or sponsor procedures, international or national regulations and Good Clinical Practices.
- Projecting, planning, developing, implementing, and delivering quality results in a timely manner. This will require the use of data, measurements and a systematic approach and is accomplished specifically by:
- Interpreting the Clinical Protocol to ensure the accurate and efficient design of the CRF.
- Analyzing metrics surrounding the activities associated with the acquisition, documentation, review, cleaning, and processing of clinical data.
- Interpreting study timelines and prioritizing workload appropriately.
- Coordinating and managing the activities of a CDM trial team, typically comprised of Clinical Programmers, Clinical Data Associates and Coding Specialists. This includes reviewing and approving all documents issued by the Clinical Data Management trial team.
- Participating in Clinical Data Management initiatives, to contribute to the continuous improvement of the processes and technologies utilized within the department.
- Ensuring Data Management tasks are performed according to the work orders, which describes the specific CDM activities and time for completion, contracted with the Sponsor Company and central laboratory, while ensuring adherence to federal regulations, Good Clinical Practice and Good Clinical Data Management Practices.
- Minimum of 8 years clinical data management experience, preferably in pharmaceutical research and development or related field.
- Bachelor's degree in a life sciences field, preferred.
- Experience and ability to work independently, as well as manage several diverse projects simultaneously, under tight time constraints.
- Ability to engage and demonstrate cooperative behavior to lead team efforts.
- Experience in responding rapidly to changing priorities and in managing aggressive deadlines.
- Excellent written and verbal communication skills. Extensive experience in communicating with all levels of personnel, in domestic and international environments.
- Demonstrated experience in leading and participating in collaborative work teams.
- Strong leadership abilities and interpersonal skills.
- Accurately and efficiently work toward quality results, creation of new processes and procedures, and decision-making based on precedent, company policies, federal regulations, Good Clinical Practice and Good Clinical Data Management Practices.
- Independent decision making and implementation.
- Excellent communication, organization, problem solving and project management skills.
- Working knowledge of medical terminology, federal regulations, Good Clinical Practice, CDISC standards and Good Clinical Data Management Practices.
- Medical, Dental, Vision coverage (Company contributes significantly to premiums)
- 20 days PTO + 13 Paid Holidays
- 100% employer matching 401(k)
- Short & Long-term disability benefits
Benefits Offered?
- No
Bonus Offered?
- No
Travel Required?
- No
Experience:
- Mid-Senior level
Remote Job:
- Yes
Global Experience Needed?
- No
Specialized Experience Needed?
- No
Apply before:
- Apr 18, 2024
Company Overview
Peachtree BioResearch Solutions
Current Openings: 0
Over 10 years ago, Peachtree was founded to fill a perceived missing principle in typical CRO services. Where can I find a CRO that will partner with me, understand my challenges, and solve issues to keep my program on track? Filling this need requires experienced clinical research professionals. We focused on people – building an organization by investing in highly experienced personnel with broad therapeutic area expertise in a number of clinical trials. From single-center Phase I to global multi-center trials. Most all of our clinical personnel have both sponsor and CRO experience – allowing us to fully understand the issues our sponsor-clients face. We built a rock-solid processes and systems infrastructure to support the teams and this investment continues today – always seeking to improve our service. We also saw the opportunity to support an under-served segment of the market – emerging mid-sized companies. We felt they could benefit from access to highly-experienced teams that understand the challenges of limited resources and be flexible, reliable, and responsive. Most of all – provide solutions. So where is Peachtree today? 🍑 A full-service CRO offering project management, feasibility & subject recruitment, clinical site management & monitoring, data management, biostatistics, medical monitoring, medical writing, and clinical quality assurance 🍑 We are 80+ highly-experienced clinical research professionals with an average of more than 20 years relevant clinical experience 🍑 Our client roster continues to grow having worked with nearly 100 pharmaceutical, biotech, and medical device companies providing full-service clinical trial support to niche services 🍑 Continued investment in best-in-class systems such as IBM Clinical for EDC, Veeva Vault for eTMF, ZenQMS for quality management and training, and Oracle for CTMS.
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