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SR.CLINICAL RESEARCH MANAGER
Position Description
This position requires strong leadership skills and the ability to manage people, deliver on clinical projects, and align with business initiatives. This person will be the clinical representative on a therapy team and oversee project plans and develop clinical evaluation projects; this includes oversight on clinical strategy, clinical plan, and conducting clinical studies on products and/or therapies in accordance with good scientific principles and pertinent government regulations. This person must possess strong communication (oral and written) skills.
This position requires strong leadership skills and the ability to manage people, deliver on clinical projects, and align with business initiatives. This person will be the clinical representative on a therapy team and oversee project plans and develop clinical evaluation projects; this includes oversight on clinical strategy, clinical plan, and conducting clinical studies on products and/or therapies in accordance with good scientific principles and pertinent government regulations. This person must possess strong communication (oral and written) skills.
The position (in Santa Rosa) will have more of a medical affairs, post marketing study focus. Building a post approval team including development of processes, systems and SOPs.
Managing Managers, There will 6-8 direct reports ( managers)
Excellent writing skills, writing IDE’s experience
Class III medical device experience.
Position Responsibilities
Manages clinical study personnel focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies. Provides leadership and strategic oversight in determination of study objectives, strategy, scope and schedule in order to meet business needs including; implementation of clinical plans, management and analysis of clinical data.
As the clinical representative on a therapy team attend regular team meetings and provide updates, contribute to the therapy team’s strategy, and assure that the clinical strategy aligns with the therapy team strategy. Provides direction to development teams, facilitates bi-directional communication between core team and functional area.
Recruit, hire internal and external resources to conduct clinical studies in accordance with good scientific principles and pertinent government regulations. Research, prepare, and revise the Investigational Plan and other appropriate sections of the study in consultation with the cross-functional project team. Manages activities performed by Contract Research Organizations.
This person may serve as a medical/scientific advisor regarding tasks, projects, and operations. This person may be required to interpret results of clinical investigations or conduct literature searches in preparation for new-drug, therapy or device application review. Participate in training to enhance knowledge base and may attend relevant scientific and/or medical meetings.
Will interface with Research and Development, Marketing, and Program Management where needed to ensure the accuracy, timely review, and dissemination of all cross-functional documentation.
Performs the following tasks independently:
• Develops required clinical documents to meet phase review requirements (e.g., Clinical Strategy, Claims Matrix, Investigator Brochure, Clinical Management Plan, Clinical Investigational Plan)
• Ensures that projects are completed on schedule and within budget, responsible for projects assigned to the section(s) or department(s)
• Manages talent (direct reports) through coaching, mentoring and training, sets objectives and completes performance reviews
• Critically evaluates clinical data/information. Interfaces in a supporting role with regulatory agencies including pre-IDE meetings with the Food and Drug Administration (FDA) and responding to questions as required
Manages clinical study personnel focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies. Provides leadership and strategic oversight in determination of study objectives, strategy, scope and schedule in order to meet business needs including; implementation of clinical plans, management and analysis of clinical data.
As the clinical representative on a therapy team attend regular team meetings and provide updates, contribute to the therapy team’s strategy, and assure that the clinical strategy aligns with the therapy team strategy. Provides direction to development teams, facilitates bi-directional communication between core team and functional area.
Recruit, hire internal and external resources to conduct clinical studies in accordance with good scientific principles and pertinent government regulations. Research, prepare, and revise the Investigational Plan and other appropriate sections of the study in consultation with the cross-functional project team. Manages activities performed by Contract Research Organizations.
This person may serve as a medical/scientific advisor regarding tasks, projects, and operations. This person may be required to interpret results of clinical investigations or conduct literature searches in preparation for new-drug, therapy or device application review. Participate in training to enhance knowledge base and may attend relevant scientific and/or medical meetings.
Will interface with Research and Development, Marketing, and Program Management where needed to ensure the accuracy, timely review, and dissemination of all cross-functional documentation.
Performs the following tasks independently:
• Develops required clinical documents to meet phase review requirements (e.g., Clinical Strategy, Claims Matrix, Investigator Brochure, Clinical Management Plan, Clinical Investigational Plan)
• Ensures that projects are completed on schedule and within budget, responsible for projects assigned to the section(s) or department(s)
• Manages talent (direct reports) through coaching, mentoring and training, sets objectives and completes performance reviews
• Critically evaluates clinical data/information. Interfaces in a supporting role with regulatory agencies including pre-IDE meetings with the Food and Drug Administration (FDA) and responding to questions as required
Basic Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required:
KNOWLEDGE/EDUCATION
• Bachelor’s degree (technical or non-technical). Technical degree defined as engineering, life sciences or related medical/scientific field
• Advanced degree (e.g., MS, MA, MPH, PharmD, PhD, DVM or MD) in scientific field of study preferred. MS, MA or MPH with at least 6 years experience supporting research or PharmD, PhD, DVM, or MD with at least 4 years experience supporting industry sponsored clinical research
• PharmD, PhD, MD, DVM or foreign equivalent will substitute for 2 years of experience
JOB EXPERIENCE
• 6+ years experience managing complex clinical research studies and study teams
• 2-5 year clinical study personnel management (i.e., direct people management)
• Experience managing cardiovascular medical device and/or pharmaceutical trials. Familiar with Medical Device and/or combination product trials and regulations
• Proven experience leading and mentoring clinical teams
• Proficient knowledge of medical terminology
• Strong prioritization and organizational skills, good problem-solving skills
SKILLS/COMPETENCIES
• Candidates must be independent critical thinkers, deadline and detail oriented, and able to manage multiple projects in a fast-paced environment. Project management in a matrix environment: facilitation and negotiation; time/resource management; drive to clear objectives
• Advanced written, oral, and interpersonal communication skills including proficient knowledge of medical terminology. Significant knowledge of clinical and outcomes research study design
• Strong Computer skills (MS Office products, word processing, spreadsheets, etc.)
• Proficiency in the use of technical publication tools. Ability to write technical summaries and to read, analyze, and interpret common scientific and technical journals
PHYSICAL REQUIREMENTS
• Travel up to 30%Technical
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required:
KNOWLEDGE/EDUCATION
• Bachelor’s degree (technical or non-technical). Technical degree defined as engineering, life sciences or related medical/scientific field
• Advanced degree (e.g., MS, MA, MPH, PharmD, PhD, DVM or MD) in scientific field of study preferred. MS, MA or MPH with at least 6 years experience supporting research or PharmD, PhD, DVM, or MD with at least 4 years experience supporting industry sponsored clinical research
• PharmD, PhD, MD, DVM or foreign equivalent will substitute for 2 years of experience
JOB EXPERIENCE
• 6+ years experience managing complex clinical research studies and study teams
• 2-5 year clinical study personnel management (i.e., direct people management)
• Experience managing cardiovascular medical device and/or pharmaceutical trials. Familiar with Medical Device and/or combination product trials and regulations
• Proven experience leading and mentoring clinical teams
• Proficient knowledge of medical terminology
• Strong prioritization and organizational skills, good problem-solving skills
SKILLS/COMPETENCIES
• Candidates must be independent critical thinkers, deadline and detail oriented, and able to manage multiple projects in a fast-paced environment. Project management in a matrix environment: facilitation and negotiation; time/resource management; drive to clear objectives
• Advanced written, oral, and interpersonal communication skills including proficient knowledge of medical terminology. Significant knowledge of clinical and outcomes research study design
• Strong Computer skills (MS Office products, word processing, spreadsheets, etc.)
• Proficiency in the use of technical publication tools. Ability to write technical summaries and to read, analyze, and interpret common scientific and technical journals
PHYSICAL REQUIREMENTS
• Travel up to 30%Technical
Job Details
| Name: | Donne Paine | Date Posted: | 10/13/2009 |
| Office: | Hilton Head | Telephone: | (843) 842-7221 |
| Email: | donne@fpchh.com | Fax: | |
| Category: | Clinical Research | ||
| Keywords: | SR Manager Clincial Research Manager Manager class III medical devices Cardiovascular | Region: | West (CA, HI, NV, UT) |
| State: | City: | ||
| Education: | BS, MA, MS, PhD | Job Number: | J57424-HTHD- |
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