Id: 166412 Location: Malvern, PA Job Type: Contract One of our leading clients, an international. Pharmaceutical company focused generics and specialty branded drugs is seeking an Clinical Scientist Consultant provide medical and scientific study and project support for multiple, global, Phase 1-4 clinical studies in a clinical program . Clinical Scientist responsible for working collaboratively with the Clinical Program Lead Physician to develop study strategies in support of the clinical plans.
The Clinical Scientist support includes multiple tasks within the categories of:
Protocol and study design, strategy, and training,
Data review and interpretation,
Study and/or program scientific and integrity oversight,
Safety review and communication,
Regulatory document, study report and publication preparation and review
Clinical study implementation oversight, with a critical focus on consistency, quality, data integrity, safety, and alignment with company values.
The Clinical Scientist may be assigned to lead implementation of program level activities identified by the Lead Clinical Scientist and Clinical Lead Physician as needed.
1) PROTOCOL AND STUDY DESIGN
Create protocol training materials for site management
Provide specific medical/protocol training for site facing roles
Provide site medical/protocol training for use during site initiation visits
Provide protocol training at the investigator meeting
Assist in preparation for and participate in consultant and key opinion leader meetings
Complete clinical sections of the Site Reference Manual
Provide input on country feasibility as delegated by the Clinical Program Lead and/or Lead Clinician
Independently write/design protocol outlines, protocols, and amendments of moderate complexity in collaboration with the Lead Clinician, Statisticians, and other relevant groups
Lead strategy discussions of moderate complexity
Create informed consent form templates, and review site prepared ICFs
Support the preparation of other clinical documents as required
2) DATA REVIEW AND INTERPRETATION
3) STUDY MEDICAL OVERSIGHT
5) REGULATORY AND PUBLICATIONS
6) CLINICAL PROGRAM IMPLEMENTATION
Along with the Lead Clinician is accountable for the Medical/Safety/Scientific Design and Execution of a Study, with oversight of CROs and vendor activities .
Ensure regulatory compliance and GCP adherence at the study level with regard to medical/scientific issues
Initiate and coordinate corrective action for major medical/safety/scientific study level issues
Along with CPM and with regard to medical/safety concerns, ensures study level issues are resolved.
Collaborate with Lead Clinician and CPM to arrive at major site level decisions based on input from the team
Provide input during budget creation to Clinical Program Lead and Lead Clinician
Coordinates with CPM to maintain study timelines.
Along with the CPM and in agreement with the Clinical Program Lead/Lead Clinician and the Team, develops study level enrollment plan
BA/BS Degree in science or health-related field
MS, PhD or Pharm D preferred
Has extensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field.
Previous experience as Clinician preferred
Has working knowledge of Dermatology therapeutic area
Has demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documents
Has independently authored clinical protocols and other clinical study documents
Has experience with participating in and informally leading an operational team
Applies knowledge of internal/external business challenges to facilitate process improvements
Has working knowledge of statistics, data analysis, and data interpretation
Has exceptional written and oral communication and cross-functional collaborative skills
Is proficient in MS Word, Excel, and PowerPoint
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
As a well-funded pharmaceutical company, company pays highly competitive hourly rate based on W2/1099 and Corp-to-Corp. Interested individuals are encouraged to contact or submit their CV to the following email address: firstname.lastname@example.org
Search Terms: Clinical Scientist, Clinician
We appreciate your understanding, in that; we will only be able to respond to those inquiries who meet the stated requirements. To protect our client's interests, we will not be responding to inquiries that do not contain a CV/Resume. Finally, please include the position ID (rc-clinical scientist ) in the subject line of your correspondence to ensure review.
Please forward your credentials in Word format through Indeed or call Rose Chu at 610-822-1256 for questions. Our clinical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews.
Vice President - Pharmaceutical, CRO, Biotech, Medical Device
Global Employment Solutions/Fahrenheit IT
P (610)822-1256 | C (215)-317-2999 | F (610-668-5000) | email@example.com
One Presidential Blvd. North, Suite 310, Bala Cynwyd, PA 19004
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