Project Manager Sponsor-Dedicated in Germany

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Job Details

Syneos Health

has recently formed a new partnership with a leading pharmaceutical organization. Due to this new partnership, Syneos Health is seeking a

Project Manager

to be fully outsourced and dedicated to this partnership. You will act as

Study Delivery Manager

for the client and will be fully integrated in to a dynamic and friendly team.

Accountabilities for study delivery strategy and execution:

Protocol and document development to develop, review and/or finalize high quality key clinical documents including the full protocol for external and internal use in assigned trials.

Perform quality checks and follow-up on resolution of open issues to ensure cross functional study team members are compliant with use of required systems and documentation e.g. eTMF, CTMS, study team share points and others as required.

Depending on level of experience and complexity of the study, lead and coordinate all or some activities with the support of an SDL, Asset Lead and/or line Manager.

Lead or contribute to the creation and execution of effective study delivery plans aligned with program goals and timelines.
Responsibilities may include coordination of cross-functional study team activities, oversight of clinical vendor performance and metrics, planning and managing site start-up activities in collaboration with other functional lines (if Study Start-up Lead is not assigned).

May function as a liaison between clinical vendors and the sponsor to ensure understanding of expectations and scope of work.
Manage assigned study activities within agreed upon timelines and budget and in accordance with SOPs, GCP and all applicable laws and regulations.
Communicate with the cross-functional study team, the management team, and clinical vendors as required, concerning status and progress of the trial.
Collaborate and build effective working relationships with cross-functional team members.
May coordinate study team training and quality checks to ensure cross functional study team members are compliant with use of required systems e.g. eTMF, CTMS, IXRS, study team share point, and others as required.

Build and maintain solid professional relationships with key opinion leaders and clinical study site staff.
Participate in SOP, work instruction and template development and improvement initiatives.
May perform line management duties.
Study level risk register, communication, and systems data.
Conduct risk management discussions with the cross-functional study team and contribute to maintenance of a comprehensive risk management plan throughout the study lifecycle. Applies a smart-risk taking philosophy.

QUALIFICATION REQUIREMENTS

Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred.
Experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred.
Experience on a similar position.
Creative thinker - able to adapt to modern approaches to study delivery.
Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.
Effective problem solving and conflict resolution skills with a solutions-oriented mindset.
Appropriate project management skills.
Operational expertise in risk management and contingency planning.
Strong influencing and stakeholder management skills.
Strong communication skills appropriate to the target audience, promoting effective decision-making where necessary.
Ability to understand and balance the broader business needs with the needs of their specific study.
Fluency in German and English language.

LI-BC1

Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

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