Hi Associate,
| Currently, I am recruiting candidates for one of my requirement as mentioned below. If you have a matching profile, please send me the updated resume along with contact details at the earliest.
|
| Job Title | Clinical Project Manager |
| Project Location | Woodcliff Lake, Nj NJ |
| Duration | 12 months /Contract
|
Skills Required and Job Description:
Interview Mode : T +Skype
Job Summary:
The Project Manager is accountable for supporting all Medical Affairs programs. Provide critical project management support in late phase development projects over the entire life of the program. Essential Duties - Strategically develop and sustain high quality, realistic, cross functional plans for programs including clinical trials within Medical Affairs.
- Establish project deliverables by recording detailed stakeholder requirements, constraints, and assumptions with stakeholders.
- Communicate program and project plans to ensure a common understanding by stakeholders and team members.
- Collaborate with project teams and Business Operations 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.
- Define baselines and provide metrics to identify areas and trends that can be used by the teams for future enhancements.
- Responsible for understanding project and program finances from initiation to close-out. Assist with budget creation, manage the budgets. Work with financial partner to understand financial variances of actuals and projections, work with the project and program owners to resolve finance issues.
- Assist the Clinical Operations and study teams) in managing financial activity for the Study Budgets within the assigned projects. Work alongside all the clinical operation leads to understand the day to day activity of all clinical trials.
- Participates in cross-functional teams in support of continuous improvement and other management objectives.
- Partner with team leaders to tactically drive critical path elements within a program. Present clear study plans and integrate study plans with program plans.
Relationship Management: - Execute project management operational activities in accordance with approved operating plans and procedures.
- As directed by the Program Directors, provide project management support to clinical research projects in accordance with strategic plans and protocols. Interacts closely with the Clinical Operations teams to develop, monitor and execute project plans and support other key clinical activities.
- Interacts closely with key cross functional teams (i.e. Finance, Legal, Regulatory)
Qualifications: Knowledge / Skills / Abilities Required: - Minimum BS or BA in a related field; focus in biological science, or equivalent, advanced degrees and PMP certification preferred.
- PMP Certification preferred
- At least 5 years of experience in project management and significant knowledge of overall clinical drug development and general clinical research operations.
- Ability to manage multiple projects simultaneously with strong organizational planning skills.
- Strong MS Project, Excel and PowerPoint experience required. -Well developed analytical and problem solving skills. Communicates issues to senior management with action plans for resolution.
- Knowledgeable in all required regulatory and compliance standards and guidelines including ICH-GCP and assigned Client 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 processes to meet deliverables.
- PM experience in drug development and clinical trials. Pharma experience is required.
Required - Builds mutual trust and encourages respect and cooperation among team members
- Demonstrates high ethics and values, inspires loyalty and trust, handles oneself ethically following core values and beliefs.
- Builds mutual trust and encourages respect and cooperation among team
|
Thanks & Regards,
Vivek kumar
YIM/GTalk :vivekkumar.rgtalent
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