Clinical Management Opportunity With a Growing Pharmaceutical Company

One of the world?s fastest growing pharmaceutical companies is looking for an experienced clinical pharmaceutical professional to help lead their clinical pharmacology team. Our dynamic client empowers their employees to make decisions, lead, and have an opportunity to make a real difference in the work that they perform. Apply today!


General Description
Clinical Pharmacology Manager


To manage investigative sites, including selecting investigators and auditing regulatory documents to ensure compliance with company SOPs, GCPs, and applicable regulatory requirements. To assist in protocol and report writing, designing case report forms, and development of submission documents and responses to FDA requests. To coordinate Population PK and PK/PD analyses using Phase III data. To select, hire, train, and supervise CRAs/Sr. CRAs.


Skills Required


BS in Science or Health related discipline (graduate degree ? optional), with 5 years of pharmaceutical industry experience (clinical research a plus).
Experience running and maintaining clinical trials in the oncology therapeutic area.
Must have extensive knowledge of GCPs and ICH guidelines.
Must have excellent oral and written communication skills.
Demonstrated organizational skills.
Must be able to travel up to 35% of the time.


Major Responsibilities


Assists with protocol writing and designing case report forms.
Circulates final protocols for approval.
Selects and evaluates investigators.
Manages investigative sites and clinical study program(s).
Audits consent documents/regulatory files, clinical studies and drug accountability.
Reports progress on multiple clinical study programs.
Reviews/approves data review guidelines.
Writes clinical reports/departmental SOPs.
Supervise CRAs/Sr. CRAs.
Tracks and reports study site progress.
Proficiency in data management process.
Reviews/executes Clinical Trial Agreements.
Negotiates/approves clinical study budgets.
Identifies/manages and audits CROs, vendors, and consultants.
Assists medical directors in short and long term planning, the preparation of IND Annual Report for medical approval and in the preparation/revision of investigational brochure.
Leads and participates in Project Team Meetings.
Monitors literature, including: therapeutic, competitive, and technical.
Identifies training and development programs for self and CRAs/Sr. CRAs.
Conducts performance reviews for CRAs/Sr. CRAs.
Acts as resource for clinical pharmacology-related questions
Coordinate and support Population PK and PK/PD analyses of Phase III data.
Provide support and input into responses to FDA requests and queries as well as submission documents
Provide clinical pharmacology input into process improvement initiatives


Full Relocation Package Available

For more jobs in the pharmaceutical industry just like the above opportunity, go to: www.MBR-Associates.com