Sponsor Dedicated Global Project Manager II - remote in one of the following countries - Belgium, UK, Denmark, Germany, Italy, Poland or Spain. Good to have Post-Trial Access (PTA) and Expanded Access Program (EAP) experience Syneos Health Healthcare Careers – Barcelona, Barcelona
Sponsor Dedicated Project Manager II - Belgium, Denmark, Germany, Italy, Poland or Spain.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.
Job responsibilities
Develop and maintain study project plan covering all study related activities/timeline tracking and review regularly with study team.
Ensure timelines for design, build and release of production database are in alignment with First site activated.
Define what reports from Database Programming are required for each study above and beyond the standard DM reports.
Ensure Medical Monitor has access to lab portal and alerts; SAE, ECG or other alerts, as applicable.
Develop process for Selection of Coordinating Investigator, if applicable.
Develop/Implement process for Site activation, IP release, kit delivery, systems access etc at time of Regulatory Green light.
Ensure processes are in place to Develop Country-Specific Informed Consent Form(s).
Ensure Implement of escalation process for timely Creation, collection and approval Site Regulatory Packages in both internal and external models.
Central IRB/EC Management.
Oversight of Regulatory submission process timelines.
Ensure implementation of contracts with DMC, scheduling of meetings and coordinating cross-functional timelines for data cuts.
Investigator Meeting(s): Accountable for all meeting decisions, budget, and planning.
Oversee and direct activities relative to Financial Disclosure Tracking and Define plan for collection of FD information one year after trial completion.
Plan Operational Overview Meetings following feasibility, as required (coordinate slides, meeting planning, etc.)
iCORE: Determine/Maintain milestones and ensure study updates are performed appropriately by team members.
Facilitate key stakeholder communication (i.e. MSL, Project Management, TOMs, EU Medical Affairs, etc.)
Ensure appropriate resource(s) have been requested.
Establish monitoring requirements for monitoring plan. Oversight of Monitors/monitoring visit management/findings from visits.
Status Update slides (enrollment, site start-up, clinical supplies, safety monitoring, etc)
Provide information for Annual Reports such as IND updates, NDA, DSUR.
Manage CROs and vendors to agreed Scope of Work and ensure work is not occurring out of scope without appropriate approvals.
Contribute to Protocol development and review.
Feasibility: Oversight of the Feasibility and site selection process.
Request Vendor Selection meeting.
Vendor management (issue escalation, oversight, accountability, invoice approval and budget oversight)
Manage timelines related to Data transfers with vendors to cross functional teams data management/Programming/Stats/PK/TS etc.
Work with team to contribute to completion of Clinical Data Review Plan (CDRP).
Ensure development of CRF Completion Guidelines and entry requirements.
Attend Specification Review Meetings (SRM) and contribute to CRF design.
Develop/Review/Approve Study Plans and Manuals as applicable (i.e. Monitoring, Communication, Cohort, Risk Management, Safety, Recruitment, Training, Pharmacy, Laboratory, ECG, etc.).
Work with the Director of monitoring to approve Selection of CRO monitoring team (eg, qualifications, location).
Qualifications
What we're looking for
• Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
• Solid Global Project Management experience gained from both a CRO and Pharma company. A strong background in study oversight, IP management, Vendor Management and Project Planning.
• Strong organizational skills.
• Strong ability to manage time and work independently.
• Direct Oncology therapeutic area expertise.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information:
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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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