$133,579–$173,480 Per Year
Allergies, Budgeting, Case Report Form (CRF), Clinical Data, Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Management, Clinical Practices/Protocols, Clinical Trial, Clinical Trial Management, Communication Skills, Computer Skills, Contract Research Organization (CRO), Data Management, Database Design, Dermatology, FDA Requirements, GCP (Good Clinical Practices), Healthcare, ICH Regulations, Immunology, Interpersonal Skills, Microsoft Excel, Microsoft Outlook, Microsoft Word, Multitasking, Organizational Skills, Policy Implementation, Presentation/Verbal Skills, Protocol Analysis, Reconciliation, Requirements Management, Standard Operating Procedures (SOP), Statistics, Systems Administration/Management, Team Player, Time Management, Training/Teaching Materials, Writing Skills
Overview
The Senior Clinical Data Manager is responsible for managing the data management activities for multiple clinical trials. Will work closely with internal team members and vendors to ensure that assigned clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and expectations, and budget.
Responsibilities
- Oversee CRO data management counterparts for assigned clinical trials and ensure that the data management objectives are met in accordance with current SOPs, WPDs and timelines and budget.
- Initiate CRF development for new clinical trials and protocol amendments; collaborate with internal team and responsible vendor on CRF development, database design and edit specifications. Ensure established clinical data standards are followed.
- Review CRO Data Management Plans, Data Review Plans and other applicable data management documents for completeness and accuracy.
- Create internal Data Review Plans for review/approval by study team members and coordinate the internal data review process; proficient in data review; oversee and track clean patient status.
- Review/create Data Transfer Plans for external data vendors for review/approval by study team members; perform external data reconciliations as applicable
- Review protocols, Statistical Analysis Plans and statistical outputs taking CRF/Database into consideration.
- Assist in the creation/review of clinical data standards, DM WPDs and Instruction Documents.
Qualifications
- Completed BA/BS degree is required, with a concentration in a scientific or health care field preferred.
- 5+ years prior experience in clinical data management
- Proficient in Medidata Rave; strong understanding of system configuration requirements and specifications.
- Experience with clinical data standards; knowledge of CDISC standards
- Preferred experience with immunology, dermatology and allergy
- In-depth knowledge of data management, including interpretation and implementation of FDA regulations
- Ability to work within established timelines, in a fast-paced environment, managing multiple clinical trials, non-study projects, and ad-hoc assignments/lCH guidelines, and GCP is required
- Excellent oral and written communication skills
- Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact
- Excellent organizational, multitasking, and priority management skills
- Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook
CompensationThe expected base salary range for this position is $133,579 to $173,480
We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.
Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach
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Celldex Therapeutics Inc