Project/Program Manager- Medical Affairs (12 month contract): Career Developers
| Job ID | TY101578 |
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| Company Name | Career Developers |
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| Job Category | Pharmaceutical/Biotech |
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| Location | Montvale, NJ |
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| Position Type | Full-Time, Contract |
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| Experience | 5-10 Years Experience |
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| Date Posted | October 29, 2009 (Reposted Nov 12) |
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| View Career Developers profile and job listings |
Project Manager with recent hands-on clinical drug development and/or general clinical research exp.
Employment agency specializing in Information Technology,
Life Sciences
and Finance recruiting, permanent and consulting
services.
Project/Program Manager- Medical Affairs (12 month contract)
Woodcliff Lake, NJ
The Project Manager is accountable for all project level support for assigned projects, work packages, and initiatives within the assigned project cluster activities. Provide critical project management support in late phase research development projects over the entire life (initiate, plan, execute, control, close). Provide project management expertise in the development and execution of strategies and objectives. Establish project deliverables by recording detailed customer requirements, constraints, and assumptions with stakeholders, using requirement-gathering techniques (e.g., planning sessions, brainstorming, focus groups) and the development of the project charter.
-Manage changes to the project scope, project schedule, & project costs using appropriate verification techniques to keep the project plan accurate, updated, reflective of authorized project changes as defined in the change management plan & facilitate customer acceptance.
-Communicate project plan to ensure a common understanding by setting expectations in accordance with the Project Plan, in order to align the stakeholders and team members.
-Collaborate with project teams to develop clinical outsourcing specifications to facilitate the selection of high-quality clinical vendors and to ensure that vendor responsibilities, deliverables and payment terms are clearly defined.
-Manage and effect oversight of assigned clinical vendors and functional service providers to ensure data integrity and adherence with regulatory requirements.
-Collaborate with other team members to coordinate the development and finalization of key project documents (charters, plans, reports, analysis)
-Develop and implement project specific training programs and training materials for internal and external staff. Participates in cross-functional teams in support of continuous improvement and other management objectives.
-Interacts closely with key cross functional teams (i.e. Finance, Legal, Regulatory)
-Monitor and report project progress using standard & adhoc review & reporting procedures (i.e. project dashboards, finance latest forecast and spend, risk issue management, contracts development status)
-In collaboration with project teams, lead the development and utilization of various tracking mechanisms, manage clinical trial projects within the agreed-to parameters as defined by the project plan, proactively detect issues, escalate and provide action plans for resolution.
REQUIRED QUALIFICATIONS:
-PMP Certification Required
-At least 5-7 years of experience in project management within Medical Affairs overseeing late phase research development projects over the entire life cycle (initiate, plan, execute, control, close).
-Knowledgeable in clinical research projects, its scope and project objectives, applicable project management and business systems as well as the role and function of each team member, to effectively coordinate the activities of the team.
-Ability to manage multiple projects simultaneously with strong organizational and planning skills.
-Well developed analytical and problem solving skills. Communicates issues to senior management with action plans for resolution.
-Knowledgeable in regulatory and compliance standards and guidelines including ICH-GCP and assigned Standard Operating Procedures.
-Ability to effectively work with teams and promote collaborations in a matrix organization.
-Exceptional interpersonal skills including ability to persuade, negotiate & resolve conflicts.
-Excellent verbal and written communication skills, ability to interact with all levels of management within the organization and to external business contacts.
-Independent judgment and decision-making skills with respect to functional responsibilities. Innovative and motivated in optimizing clinical operations processes to meet deliverables.
-Minimum BS or BA in a related field; focus in biological science or nursing preferred, or equivalent, advanced degrees preferred.
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