COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
We are recruiting for our Clinical Development team in Turkey and are currently seeking to hire a Clinical Team Lead . This is a permanent, full time position, based in our Istanbul office.
About the Job
Within this position, your duties will include:
Significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements in countries. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives. As a customer-facing role, this position will build business relationships and represent Sponsor with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships.
Requires ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director. Requires strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager.
To be successful in this position, you will need to be educated to Master’s degree level (or equivalent) in life science field.
- Minimum Relevant Experience to perform the position: 8-10 years of experience for a MS/MBA/JD or 3-6 years for an MD-PhD
- Proficient English
Additionally, you will need to demonstrate:
- Ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical. Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be both direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing.
- Strong scientific and clinical research knowledge is required for this position. A strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously. Requires skills to effectively build and maintain professional relationships with investigators and other external stakeholders, requiring strong communication, educational/pedagogic, diplomatic and empathic skills.
- proven ability to collaborate and lead high performing cross-functional teams also in a virtual environment.
- strong leadership skills (scientific and business) and ability to coordinate and lead local teams to high performance. Oversee country commitments, compliance and training needs. Additionally, business leadership and alignment with corporate requires that individual has ability to lead across several dimensions simultaneously.
Works collaboratively with Country and Regional Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health internally; and with external functional outsourcing vendors. Requires coordination and alignment with the regional and broader organization. Additionally, will work to build and maintain relationships with investigators and other external partners and promote Sponsors reputation. In collaboration with CRD, represents Sponsor in Pharma industry issues and in seeking influence in external R&D environment.
The opportunity to work within an experienced and highly skilled team.
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
There is no better time to join us!
KEY WORDS: clinical research, pharma, clinical trials, clinical research associate, clinical team lead, clinical project lead, Istanbul, sponsor based
|• University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution. |
• In lieu of the above requirement, candidates with experience of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development process.
• Experience as a Senior Clinical Research Associate, whether internal or external
• PMP Qulaification
|Regional Project Manager experience in a Clinical Research Setting|
• Experience in relevant clinical research experience with an ability to demonstrate comprehensive understanding of:
• ICH/GCP guidelines;
• Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;
• Site monitoring and study site management requirements;
• Applicable regional regulatory requirements;
• Trip report review, risk planning, study plan development, resource planning and data management oversight.
• In lieu of the above requirements, candidates with > two (2) years supervisory experience in a health care setting and four (4) years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered.
• Additional requirements include:
• Demonstrated ability to work with minimal supervision.
• Demonstrated good planning and organization skills.
• Good computer skills with good working knowledge of a range of computer packages.
• Demonstrated effective and professional verbal and written communication skills.
• Ability to train, lead and develop junior staff.
• Ability to understand and work with financial information.
• Ability to resolve project-related problems and prioritizes workload for self and team.
• Ability to work collaboratively within a project team.
• Ability to work efficiently and effectively in a matrix environment.